Trial Outcomes & Findings for Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations (NCT NCT04323436)

Last Updated: 2024-10-09

Results Overview

Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Up to approximately 2 years and 4 months

Results posted on

2024-10-09

Participant Flow

Participants took part in 15 investigative sites in 9 countries.

The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study treatment. After screening, the treatment period started on Cycle 1 Day 1. The study enrollment was halted during the Run-in part per sponsor's decision. Following the study enrollment halt, spartalizumab treatment was discontinued and Part 2 was not initiated.

Participant milestones

Participant milestones
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the randomized part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Overall Study STARTED	31	0	0
Overall Study Treated With Capmatinib + Spartalizumab	28	0	0
Overall Study Treated With Capmatinib Only	3	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	31	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the randomized part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Overall Study Adverse Event	7	0	0
Overall Study Transfer to another clinical study or to other alternative treatment option	8	0	0
Overall Study Death	1	0	0
Overall Study Physician Decision	2	0	0
Overall Study Progressive disease	10	0	0
Overall Study Subject decision	3	0	0

Baseline Characteristics

Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=31 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the randomized part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.	Total n=31 Participants Total of all reporting groups
Age, Continuous	71.6 years STANDARD_DEVIATION 9.50 • n=5 Participants	—	—	71.6 years STANDARD_DEVIATION 9.50 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized White	23 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 2 years and 4 months

Population: All patients to whom study treatment had been assigned and who received at least one dose of study treatment (i.e. at least one dose of any component of the study treatment that is capmatinib or spartalizumab) in the single arm run-in part. Patients were analyzed according to the treatment they were assigned to.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=31 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1	35.5 percentage of participants Interval 19.2 to 54.6	—

PRIMARY outcome

Timeframe: Up to 6 years

Population: All patients to whom study treatment had been assigned and who received at least one dose of study treatment in the randomized part. The randomized part of the study was not initiated and data was not collected.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Tumor response based on blinded independent review committee (BIRC) assessment per RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of capmatinib to last dose, up to 2.4 years

Population: All patients to whom study treatment had been assigned and who received at least one dose of capmatinib in the single arm run-in part. Patients were analyzed according to the treatment they were assigned to.

Number of participants with at least one dose reduction of capmatinib and number of participants with at least one dose interruption of capmatinib.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=31 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib At least one dose reduction	19 Participants	—
Run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib At least one dose interruption	20 Participants	—

SECONDARY outcome

Timeframe: From first dose of spartalizumab to last dose, up to 0.9 years

Population: All patients to whom study treatment had been assigned and who received at least one dose of spartalizumab in the single arm run-in part. Patients were analyzed according to the treatment they were assigned to.

Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab. Dose reductions were not allowed for spartalizumab.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=28 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab At least one dose reduction	0 Participants	—
Run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab At least one dose interruption	7 Participants	—

SECONDARY outcome

Timeframe: From first dose of capmatinib to last dose, up to 2.4 years

Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=31 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Dose Intensity of Capmatinib	595.9 mg/day Standard Deviation 173.6	—

SECONDARY outcome

Timeframe: From first dose of spartalizumab to last dose, up to 0.9 years

Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in days and then multiplied by the duration of one cycle (28 days).

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=28 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Dose Intensity of Spartalizumab	365.6 mg/cycle Standard Deviation 51.5	—

SECONDARY outcome

Timeframe: Up to approximately 2 years and 4 months

DCR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and non-CR/non-progressive disease (for subjects without target lesions). Tumor response was based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression).

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=31 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1	77.4 percentage of participants Interval 58.9 to 90.4	—

SECONDARY outcome

Timeframe: Up to approximately 2 years and 5 months

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on investigator assessment per RECIST v1.1. Progression is defined using RECIST v1.1 as at least 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. PFS was analyzed using Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=31 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1	16.5 months Interval 7.4 to Not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 3 Day 1. The duration of one cycle was 28 days.

Population: Patients in the capmatinib full pharmacokinetic analysis set (INC-FPAS) with an available value for the outcome measure. INC-FPAS consists of all patients who had an extensive PK sampling and provided a capmatinib evaluable PK profile on Cycle 3 Day 1.

Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=7 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Capmatinib	2730 ng/mL Geometric Coefficient of Variation 74.3	—

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 3 Day 1. The duration of one cycle was 28 days.

PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=7 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib	1.75 hours Interval 1.0 to 3.92	—

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 3 Day 1. The duration of one cycle was 28 days.

PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUCtau calculation. A dosing interval (tau) is defined as 12 hours. The portion of area under the curve between 8 hours and 12 hours post-dose was calculated by extrapolation based on terminal elimination slop.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=3 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Area Under the Plasma Concentration-time Curve From Time Zero to the End of a Dosing Interval (AUCtau) of Capmatinib	12900 hr*ng/mL Geometric Coefficient of Variation 96.1	—

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 3 Day 1. The duration of one cycle was 28 days.

PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=7 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib	10000 hr*ng/mL Geometric Coefficient of Variation 61.8	—

SECONDARY outcome

Timeframe: pre-infusion and 1, 72, 168, 336 and 672 hours after completion of the spartalizumab infusion on Cycle 3 Day 1. The duration of the infusion was approximately 30 minutes. The duration of one cycle was 28 days.

Population: Patients in the spartalizumab full pharmacokinetic analysis set (PDR-FPAS) with an available value for the outcome measure. PDR-FPAS consists of all patients who had an extensive PK sampling and provided a spartalizumab evaluable PK profile on Cycle 3.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=9 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Maximum Observed Serum Concentration (Cmax) of Spartalizumab	135 µg/mL Geometric Coefficient of Variation 28.4	—

SECONDARY outcome

PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=9 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab	1.67 hours Interval 0.917 to 164.0	—

SECONDARY outcome

PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUCtau calculation. A dosing interval (tau) is defined as 28 days.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=8 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Area Under the Serum Concentration-time Curve From Time Zero to the End of a Dosing Interval (AUCtau) of Spartalizumab	49700 hr*µg/mL Geometric Coefficient of Variation 47.8	—

SECONDARY outcome

PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Outcome measures
Measure	Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W n=9 Participants Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab 400 mg intravenously every 28 days (Q4W) in the run-in part.	Randomized Part: Capmatinib 400 mg BID + Placebo Capmatinib 400 mg orally twice daily (BID) in combination with spartalizumab matching placebo intravenously every 28 days (Q4W) in the randomized part.
Run-in Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab	52900 hr*µg/mL Geometric Coefficient of Variation 64.6	—

SECONDARY outcome

Timeframe: Up to 12 years

OS is defined as the time from date of start of treatment to date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Dose intensity is defined as the ratio of actual cumulative dose and duration of exposure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Tumor response based on investigator assessment per RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) and Partial Response (PR). Tumor response based on BIRC and local investigator assessment per RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

DOR is defined as the time from the date of first documented response (CR or PR) to the first documented progression per RECIST 1.1 or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

TTR is defined as the time from the date of start of treatment to the first documented response of either CR or PR, which must be subsequently confirmed, according to RECIST 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/QoL scale. All scales and single-item measures range in score from 0 to 100. For the functional and the global QoL scales, a higher score indicates better health. For the symptom scales, a higher score indicates more symptom burden. The QLQ-C30 summary score (0-100) is calculated as the mean of 13 of the 15 QLQ-C30 scale and item scores (excluding global QoL and financial impact), with a higher score indicating a better health-related QoL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

The EQ-5D-5L is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L contains one item for each of five dimensions of health-related quality of life (HRQOL) (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Response options for each item vary from having no problems to extreme problems. Subject responses to the five dimensions of HRQOL reflect a specific health state that corresponds to a population preference weight for that state on a continuous scale of 0 (death) to 1 (perfect health). A visual analog scale (ranging from 0 to 100) is also included to capture subject's rating of their overall health status. Higher scores of the EQ-5D-5L represent better health states.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

EORTC QLQ-LC13 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The five domains of the LC13 include pain in chest, dyspnea, coughing and hemoptysis, and are based on their presence over the past week. All but the pain domain are scored on a 4 point Likert scale ranging from "not at all" to "very much". Pain score is based on its presence, hence yes or no. Scores are averaged and transformed to 0 to 100. A higher score indicates a higher presence of symptoms. The time to definitive 10 points deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the corresponding scale score or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/QoL scale. All scales and single-item measures range in score from 0 to 100. For the functional and the global QoL scales, a higher score indicates better health. For the symptom scales, a higher score indicates more symptom burden. The time to definitive 10 points deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the corresponding scale score or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Pharmacokinetic (PK) parameters calculated based on capmatinib and spartalizumab concentrations in plasma and serum, respectively, by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Pharmacokinetic (PK) parameters calculated based on capmatinib and spartalizumab concentrations in plasma and serum, respectively, by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) concentration following a dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Pharmacokinetic (PK) parameters calculated based on capmatinib and spartalizumab concentrations in plasma and serum, respectively, by using non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Pharmacokinetic (PK) parameters calculated based on capmatinib and spartalizumab concentrations in plasma and serum, respectively, by using non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose), up to 6 years

Immunogenicity (IG) evaluated in serum samples. The assay to quantify and assess the IG was a validated homogeneous enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome data not reported

Adverse Events

Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab)

Serious events: 11 serious events

Other events: 25 other events

Deaths: 4 deaths

Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (After Discontinuing Spartalizumab)

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Run-in Part: Capmatinib 400mg BID Only

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER