A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Hoffmann-La Roche

Summary

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy * Measurable disease, as defined by RECIST v1.1 * No prior systemic treatment for advanced or metastatic NSCLC * Documentation of the presence of a KRAS G12C mutation * Documentation of known PD-L1 expression status in tumor tissue * Availability of a representative tumor specimen * Adequate end-organ function * Eligible to rec…

Interventions

Drug
Divarasib
Divarasib will be administered orally QD
Drug
Pembrolizumab
Pembrolizumab will be administered via IV infusion Q3W
Drug
Pemetrexed
Pemetrexed will be administered via IV infusion Q3W
Drug
Carboplatin
Carboplatin will be administered via IV infusion Q3W
Drug
Cisplatin
Cisplatin will be administered via IV infusion Q3W

Summary

Eligibility

Interventions

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