A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer
Janssen Research & Development, LLC
Summary
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \[RP2CD\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \[change\] in the kirsten rat sarcoma viral oncogene homolog \[KRAS\] gene in tumor cells in which glycine \[G\] at position 12 is replaced with cystine \[C\]).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAmivantamab
Amivantamab will be administered.
- DrugOlomorasib
Olomorasib will be administered.
Locations (15)
- University of California IrvineIrvine, California
- New York University Langone Medical CenterNew York, New York
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania
- Oncology Consultants Cancer CenterHouston, Texas
- Virginia Cancer SpecialistsFairfax, Virginia
- NorthWest Medical Specialties, PLLCPuyallup, Washington