KaRAnaSa
Lung cancer
A Phase 1/2, nonrandomized, open-label study of amivantamab in combination with olomorasib in patients with metastatic NSCLC
Phase
Compound
Amivantamab (EGFR × MET bispecific Ab) + olomorasib
NCT identifier
NCT07227025
Enrollment
N=~60
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Metastatic NSCLC
- KRAS G12C mutation
- KRAS inhibitor naive
- Progression on or after platinum-based chemo and PD-1 inhibitor
- Other driver mutations excluded
Study
design
Primary outcomes:
- Phase 1: Safety
- Phase 1: DLTs
- Phase 2: ORR
Secondary outcomes†:
- Safety
- Phase 2: DOR
- Phase 2: DCR
- Phase 2: PFS
- Phase 2: OS
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of outcomes.
Ab, antibody; DLT, dose-limiting toxicity; DCR, disease control rate; DOR, duration of response; EGFR, epidermal growth factor receptor; KRAS, Kirsten rat sarcoma; MET, mesenchymal epithelial transition; NSCLC, non–small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death 1; PFS, progression-free survival; RP2CD, recommended Phase 2 combination dose.