A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase 1: Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to approximately 3 years 2 months
Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to approximately 3 years 2 months
Phase 2: Confirmed Objective Response Rate (ORR)
Time frame: Up to approximately 3 years 2 months
Secondary Endpoints
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Phase 2: Duration of Response (DoR)
Eligibility Criteria
Inclusion criteria: * Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted * Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated * May have brain metasta…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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