Phase 1 (Combination Dose Selection) for Carcinoma, Non-Small-Cell Lung
Phase-Based Progress Estimates
Effectiveness
Safety
Universitaetsklinikum Essen, Essen, Germany
Carcinoma, Non-Small-Cell Lung
Capmatinib - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 11 Secondary · Reporting Duration: Up to 2 years 1 month
Year 2
Phase 2 (Cohort 1A): Change from Baseline in Health-related Quality of Life in (HRQoL) as Assessed by European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Day 28
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Year 2
Phase 1: Number of Participants with AEs by Severity
Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Phase 1: Number of Participants with Adverse events (AEs) by Severity
Phase 2 (Cohort 1A): HRQoL as Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Score
Phase 2 (Cohort 1A): HRQoL as Assessed by Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) Scale Score
Phase 2 (Cohort 1A): HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form Version 2.0 - Physical Function 8c (PROMIS PF 8c) Scale Score
Phase 2 : Duration of Response (DoR)
Phase 2: Disease Control Rate (DCR)
Phase 2: Objective Response Rate
Phase 2: Overall Survival (OS)
Phase 2: Progression Free Survival (PFS)
Phase 2: Time to Subsequent Therapy (TTST)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Phase 1 (Combination Dose Selection)
1 of 2
Phase 2 (Dose Expansion)
1 of 2
Experimental Treatment
147 Total Participants · 2 Treatment Groups
Primary Treatment: Phase 1 (Combination Dose Selection) · No Placebo Group · Phase 2
Phase 1 (Combination Dose Selection)Experimental Group · 2 Interventions: Capmatinib, Amivantamab · Intervention Types: Drug, Drug
Phase 2 (Dose Expansion)Experimental Group · 2 Interventions: Capmatinib, Amivantamab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
2018
Completed Phase 2
~20
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years 1 month
Closest Location: The Ottawa Hospital Research Institute · Ottawa, Canada
2011First Recorded Clinical Trial
1 TrialsResearching Carcinoma, Non-Small-Cell Lung
14 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s).
You have an ECOG performance status of 0 or 1.
You are a female participant of childbearing potential who is not pregnant and who agrees to a serum or urine pregnancy test at screening and within 72 hours of the first dose of study treatment.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments