N=~1000
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Key eligibility criteria*:
- Histologically or cytologically confirmed adenocarcinoma of left-sided colorectal cancer
- Unresectable or metastatic disease
- Measurable disease according to RECIST v1.1
- KRAS, NRAS, and BRAF WT
- ECOG PS 0 or 1
Primary outcome:
- PFS by BICR
Secondary outcomes†:
- OS
- Objective response rate by BICR and INV
- PFS by INV
- DOR by BICR and INV
- PFS2
- DCR by BICR and INV
- AEs by severity
- HRQoL
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
AE, adverse event; BICR, blinded independent central review; BRAF, v-Raf murine sarcoma viral oncogene homolog B1; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FOLFIRI, 5-fluorouracil, leucovorin, and irinotecan; HRQoL, health-related quality of life; INV, investigator assessment; KRAS, Kirsten rat sarcoma viral oncogene homolog; mFOLFOX6, 5-fluorouracil, leucovorin, and oxaliplatin; NRAS, neuroblastoma RAS viral oncogene homolog; OS, overall survival; PFS, progression-free survival; PFS2, progression-free survival after subsequent therapy; R, randomized; RECIST, Response Criteria in Solid Tumors; SC, subcutaneous; WT, wild type.