A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Divarasib

  Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.

• Drug
  Pembrolizumab

  Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.

• Drug
  Carboplatin

  Participants will receive IV carboplatin Q3W for four 21-day cycles.

• Drug
  Cisplatin

  Participants will receive IV cisplatin Q3W for four 21-day cycles.

• Drug
  Pemetrexed

  Participants will receive IV pemetrexed Q3W.

Locations (71)