Trial Outcomes & Findings for A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14 Alterations Who Have Received Prior MET Inhibitor (NCT NCT02750215)

Last Updated: 2022-03-14

Results Overview

Objective response rate (ORR) is defined as the percentage of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is a greater than or equal to 30% decrease in the sum of the longest diameter of target lesions. ORR = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

through study completion, an average of 14 months

Results posted on

2022-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Capmatinib (INC280) Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14 Alterations Who Have Received Prior MET Inhibitor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capmatinib (INC280) n=20 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Age, Customized Age	70 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Smoking History Never	8 participants n=5 Participants
Smoking History Former	11 participants n=5 Participants
Smoking History Current	1 participants n=5 Participants
Tumor Histology Adenocarcinoma	16 participants n=5 Participants
Tumor Histology Squamous	2 participants n=5 Participants
Tumor Histology Sarcomatoid or poorly differentiated carcinoma	2 participants n=5 Participants
MET alteration Amplification	5 participants n=5 Participants
MET alteration Exon 14 skipping	15 participants n=5 Participants
Previous Chemotherapy Yes	11 participants n=5 Participants
Previous Chemotherapy No	9 participants n=5 Participants
Previous Immunotherapy Yes	7 participants n=5 Participants
Previous Immunotherapy No	13 participants n=5 Participants
Number of previous lines of therapy 1	9 participants n=5 Participants
Number of previous lines of therapy 2	3 participants n=5 Participants
Number of previous lines of therapy 3 or more	8 participants n=5 Participants
Number of previous MET-targeted therapies 1	17 participants n=5 Participants
Number of previous MET-targeted therapies 2	3 participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 14 months

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=20 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Objective Response Rate	10 percentage of participants

SECONDARY outcome

Timeframe: through study completion, an average of 14 months

Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=20 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Progression Free Survival	5.5 months Interval 1.3 to 11.0

SECONDARY outcome

Timeframe: 12 weeks

Disease control rate (DCR) will be defined as the percentage of participants with complete response, partial response, and stable disease at 12 weeks by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Complete Response (CR) is the disappearance of all target lesions. Partial Response (PR) is a greater than or equal to 30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) is a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. DCR = CR + PR + SD.

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=20 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Disease Control Rate	80 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 4 out of 20 participants had measurable brain metastases.

Intracranial response rate (IRR) will be calculated based on response assessments in the brain for patients with measurable CNS disease at baseline by RECIST v 1.1 criteria. IRR is defined as the percentage of patients with a confirmed intracranial complete response (CR) or partial response (CR) at week 12. CR is the disappearance of all target lesions and PR is a greater than or equal to 30% decrease in the sum of the longest diameter of target lesions. IRR = CR + PR.

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=4 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Intracranial Response Rate	0 percentage of participants

SECONDARY outcome

Timeframe: up to 6 months

Population: Only 2 of 22 participants had complete response (CR) or partial response (PR) per RECIST 1.1, thus they were the only ones analyzed for DOR.

Duration of response (DOR) will be calculated from the time of first assessment of complete response (CR) or partial response (PR) per RECIST 1.1 until the first occurrence of progressive disease (PD) or death. CR is the disappearance of all target lesions. PR is a greater than or equal to 30% decrease in the sum of the longest diameter of target lesions. PD is a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=2 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Duration of Response	3.8 months Interval 2.0 to 5.5

SECONDARY outcome

Timeframe: From date of registration through study completion, an average of 14 months

Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive. OS time for patients who are alive at the end of the study or are lost to follow up will be censored at the time of last contact. OS will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=20 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Overall Survival	11.3 months Interval 5.5 to Upper limit was not reached due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: From date of treatment start through study completion, an average of 14 months

Outcome measures

Outcome measures
Measure	Capmatinib (INC280) n=20 Participants Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Number of Participants With Treatment-related Adverse Events by Grade Grade 5	2 Participants
Number of Participants With Treatment-related Adverse Events by Grade Grade 3	8 Participants
Number of Participants With Treatment-related Adverse Events by Grade Grade 4	0 Participants

Adverse Events

Capmatinib (INC280)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Capmatinib (INC280) n=20 participants at risk Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Injury, poisoning and procedural complications Hip fracture	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
General disorders Edema limbs	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Injury, poisoning and procedural complications Wound infection	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Nervous system disorders seizure	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Nervous system disorders Stroke	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Vascular disorders Thromboembolic event	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months

Other adverse events

Other adverse events
Measure	Capmatinib (INC280) n=20 participants at risk Patients who fulfill eligibility criteria will be entered into the trial to receive capmatinib. After the screening procedures confirm participation in the research study. Participants will receive capmatinib PO BID, 21-day cycles Capmatinib (INC280): treatment with Capmatinib (INC280)
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 2/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Platelet count decreased	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Gastrointestinal disorders Vomiting	10.0% 2/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Weight gain	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Immune system disorders Allergic reaction	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Nervous system disorders Peripheral sensory neuropathy	15.0% 3/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Serum amylase increased	20.0% 4/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Metabolism and nutrition disorders Anorexia	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Alanine aminotransferase increased	15.0% 3/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Cardiac disorders Atrioventricular block first degree	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Gastrointestinal disorders Constipation	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Creatinine increased	20.0% 4/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Gastrointestinal disorders Diarrhea	10.0% 2/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Nervous system disorders Dysgeusia	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Reproductive system and breast disorders Dyspnea	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
General disorders Fatigue	35.0% 7/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Blood bilirubin increased	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Metabolism and nutrition disorders Hypocalcemia	5.0% 1/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Metabolism and nutrition disorders Hypophosphatemia	10.0% 2/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Investigations Lipase increased	20.0% 4/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
General disorders Edema limbs	65.0% 13/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Musculoskeletal and connective tissue disorders myalgia	20.0% 4/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months
Gastrointestinal disorders Nausea	35.0% 7/20 • Adverse event data were collected from the treatment start date through study completion, an average of 14 months

Additional Information

Rebecca Suk Heist, MD

Massachusetts General Hospital

Phone: 617-726-8033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place