Trial Outcomes & Findings for Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test (NCT NCT05243641)

Last Updated: 2025-06-11

Results Overview

This phase of the study uses the Bayesian Optimal Interval (BOIN) design with a 3+3 run-in to identify the maximum tolerable dose (MTD). Patients are treated in cohorts of 3 with a maximum of 27 participants. Starting with Neratinib PO dose level 1 (120 mg for Dose 1-7, then 160 mg) combined with Capmatinib PO level 1 (400 mg), with up to 12 patients per dose. The target toxicity rate for the MTD is 25%.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Cycle1 and 2, total 56 days

Results posted on

2025-06-11

Participant Flow

August 2022\~ June 2023. All recruitment was done at The University of Texas MD Anderson Cancer Center.

11 patients were accrued and assessed for eligibility and 10 patients were assigned to the cohort.

Participant milestones

Participant milestones
Measure	Phase Ib: Dose Level 1 Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily
Overall Study STARTED	7	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase Ib: Dose Level 1 Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily"	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
Overall Study Adverse Event	3	0	0	1	0	0
Overall Study Disease progression	4	0	0	2	0	0

Baseline Characteristics

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase Ib: Dose Level 1 n=7 Participants Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=3 Participants Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.	Total n=10 Participants Total of all reporting groups
Age, Continuous	46 Years n=5 Participants	—	—	39 Years n=4 Participants	—	—	44.5 Years n=8 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	—	—	3 Participants n=4 Participants	—	—	10 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	—	—	2 Participants n=4 Participants	—	—	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	4 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	5 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	1 Participants n=4 Participants	—	—	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	—	—	0 Participants n=8 Participants
Region of Enrollment United States	7 participants n=5 Participants	—	—	3 participants n=4 Participants	—	—	10 participants n=8 Participants

PRIMARY outcome

Timeframe: Cycle1 and 2, total 56 days

Population: Baseline analysis population included all participants treated.

Outcome measures

Outcome measures
Measure	Phase Ib n=10 Participants All participants who received Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily or Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
To Determine Maximum Tolerated Dose for Use in the Phase II Portion of the Trial	NA Dose level (mg) No MTD was determined since the study was terminated prematurely during phase Ib.	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 3 years

Population: Patients treated at the MTD in phase II were intended to be evaluated. However, due to the study's termination during Phase Ib, no patients were analyzed for this objective.

The overall response rate (ORR) for patients treated at the MTD in Phase II was assessed. ORR was defined as the proportion of patients who achieved a partial response or complete response as their best response. All tumor responses were evaluated according to RECIST 1.1 criteria and measured using the QIAC system.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Patients treated at the MTD in phase II were intended to be evaluated. However, due to the study's termination during Phase Ib, no patients were analyzed for this objective.

Adverse events (AEs) graded using CTCAE version 5.0: ≥ Grade 2 for non-hematological and ≥ Grade 3 for hematological AEs observed after the first protocol intervention for phase II patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 27 months

Population: The baseline analysis population included all treated participants. However, patients who discontinued the study due to toxicities before completing Cycle 2 and without a RECIST assessment after therapy were excluded.

Clinical benefit rate (CBR) is defined as the proportion of patients achieving complete response, partial response, or stable disease for ≥24 weeks, was summarized by frequency and percentage with Wilson 95% confidence intervals, overall and by dose level.

Outcome measures

Outcome measures
Measure	Phase Ib n=5 Participants All participants who received Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily or Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=2 Participants Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
To Determine Clinical Benefit Rate (CBR)	20.0 percentage Interval 3.6 to 62.4	—	—	0.0 percentage Interval 0.0 to 65.8	—	—

SECONDARY outcome

Timeframe: Up to 27 months

Population: Baseline analysis population included all participants treated.

Duration of response (DOR) is defined as the period from the date of the first occurrence of a CR or PR until the first date that progressive disease or death is documented.

Outcome measures

Outcome measures
Measure	Phase Ib n=7 Participants All participants who received Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily or Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=3 Participants Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
To Determine the Duration of Response (DOR)	NA Months No patient experienced partial response nor complete response, so duration of response is not estimable.	—	—	NA Months No patient experienced partial response nor complete response, so duration of response is not estimable.	—	—

SECONDARY outcome

Timeframe: Up to 27 months

Population: Baseline analysis population included all participants treated.

PFS is defined as the time between date of treatment start to the date of documented disease progression or death, whichever occurs first

Outcome measures

Outcome measures
Measure	Phase Ib n=7 Participants All participants who received Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily or Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=3 Participants Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
To Determine Progression Free Survival (PFS)	4.76 Months Interval 2.13 to 7.39	—	—	4.54 Months Interval 0.7 to 8.38	—	—

SECONDARY outcome

Timeframe: 2 years after enrollment

Population: All patients who received at least one dose of the study medication.

The proportion of patients in the study who are alive 2 years after enrollment on to the study

Outcome measures

Outcome measures
Measure	Phase Ib n=7 Participants All participants who received Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily or Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=3 Participants Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
To Determine 2 Year Overall Survival (OS)	14.3 Percentage	—	—	33.3 Percentage	—	—

Adverse Events

Phase Ib: Dose Level 1

Serious events: 1 serious events

Other events: 7 other events

Deaths: 6 deaths

Phase Ib: Dose Level 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase Ib: Dose Level 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase Ib: Dose Level-1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase Ib: Dose Level-2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase Ib: Dose Level 1 n=7 participants at risk Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=3 participants at risk Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
Respiratory, thoracic and mediastinal disorders Pneumothorax	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
General disorders Disease Progression	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Lung Infection	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.

Other adverse events

Other adverse events
Measure	Phase Ib: Dose Level 1 n=7 participants at risk Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 2 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level 3 Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily	Phase Ib: Dose Level-1 n=3 participants at risk Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily	Phase Ib: Dose Level-2 Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily	Phase II Subjects receive neratinib and capmatinib. The MTD determined during Phase Ib will be used.
Gastrointestinal disorders Abdominal Pain	57.1% 4/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Alanine Aminotransferase Increased	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Alkaline Phosphatase Increased	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Anorexia	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Aspartate Aminotransferase Increased	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Musculoskeletal and connective tissue disorders Back Pain	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Blood Lactate Dehydrogenase Increased	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Cardiac disorders Cardiac Disorders - Chest tightness	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Cardiac Troponin T Increased	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Gastrointestinal disorders Constipation	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	100.0% 3/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Creatinine Increased	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Dehydration	57.1% 4/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Gastrointestinal disorders Diarrhea	85.7% 6/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Nervous system disorders Dizziness	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	100.0% 3/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Ear and labyrinth disorders Ear and Labyrinth Disorders - Ear drainage	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
General disorders Edema Limbs	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Injury, poisoning and procedural complications Fall	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
General disorders Fatigue	85.7% 6/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	100.0% 3/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
General disorders Flu Like Symptoms	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Nervous system disorders Headache	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Renal and urinary disorders Hematuria	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hyperglycemia	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hypoalbuminemia	57.1% 4/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hypocalcemia	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hypokalemia	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hypomagnesemia	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Metabolism and nutrition disorders Hyponatremia	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Vascular disorders Hypotension	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Infections and Infestations - Streptococcal pharyngitis	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Psychiatric disorders Insomnia	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Reproductive system and breast disorders Irregular Menstruation	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
General disorders Localized Edema	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Lymphocyte Count Decreased	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Gastrointestinal disorders Mucositis Oral	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Musculoskeletal and connective tissue disorders Muscle Cramp	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Musculoskeletal and connective tissue disorders Myalgia	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Gastrointestinal disorders Nausea	85.7% 6/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Neutrophil Count Decreased	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
General disorders Pain	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Nervous system disorders Paresthesia	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Cardiac disorders Paroxysmal Atrial Tachycardia	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Platelet Count Decreased	42.9% 3/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Pneumothorax	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Productive Cough	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Renal and urinary disorders Proteinuria	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Skin and subcutaneous tissue disorders Rash Acneiform	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Serum Amylase Increased	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Shingles	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Cardiac disorders Sinus Bradycardia	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Sinusitis	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders - Skin lesion	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Skin Infection	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Sore Throat	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Upper Respiratory Infection	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Renal and urinary disorders Urinary Frequency	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Infections and infestations Urinary Tract Infection	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Renal and urinary disorders Urinary Urgency	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Renal and urinary disorders Urine Discoloration	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Vascular disorders Thromboembolic event	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Gastrointestinal disorders Vomiting	57.1% 4/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	66.7% 2/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Eye disorders Watering Eyes	14.3% 1/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations Weight Loss	28.6% 2/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	0.00% 0/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.
Investigations White Blood Cell Decreased	0.00% 0/7 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	33.3% 1/3 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.	— 0/0 • From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months. Adverse events were evaluated based on the CTCAE version 5.0. All study participants who received neratinib and capmatinib combination therapy were included in the safety analysis.

Additional Information

Rachel M. Layman, MD

M D Anderson Cancer Center

Phone: 713) 745-8401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place