Divarasib Phase 3 Trial for Resected KRAS G12C NSCLC
Summary
NIH has registered a Phase 3 clinical trial (NCT07541170) evaluating divarasib versus investigator's choice of pembrolizumab or nivolumab or observation in participants with resected Stage II-IIIB KRAS G12C-positive NSCLC who have not achieved pathologic complete response following neoadjuvant chemoimmunotherapy. The trial enrolls participants regardless of tumor PD-L1 status and is sponsored by Genentech, Inc.
What changed
NIH registered a Phase 3 clinical trial for divarasib, a KRAS G12C inhibitor, in resected non-small cell lung cancer. The trial will compare divarasib against investigator's choice of pembrolizumab or nivolumab or observation in patients who did not achieve pathologic complete response after neoadjuvant chemoimmunotherapy. Clinical trial sites, sponsors, and clinical operations teams should note the trial identifier NCT07541170 and inclusion criteria for competitive landscape and trial matching purposes.
Pharmaceutical companies and clinical investigators with similar KRAS G12C programs should monitor this trial's outcomes as Phase 3 results for divarasib could affect the competitive positioning of other KRAS G12C inhibitors in NSCLC. Sites considering participation should review the protocol's inclusion/exclusion criteria and comparator arm structure.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
Phase 3 NCT07541170 Kind: PHASE3 Apr 21, 2026
Abstract
The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
Conditions: Non-small Cell Lung Cancer
Interventions: Divarasib, Pembrolizumab, Nivolumab
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