Phase 1 (Combination Dose Selection) for Carcinoma, Non-Small-Cell Lung
Phase-Based Progress Estimates
Universitaetsklinikum Essen, Essen, Germany
Carcinoma, Non-Small-Cell Lung
Capmatinib - Drug
You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.
What conditions do you have?
What conditions do you have?
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).
3 Primary · 11 Secondary · Reporting Duration: Up to 2 years 1 month
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
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
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
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.
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.