A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Conditions

• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Divarasib — DRUG
  Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.
• Pembrolizumab — DRUG
  Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
• Carboplatin — DRUG
  Participants will receive IV carboplatin Q3W for four 21-day cycles.
• Cisplatin — DRUG
  Participants will receive IV cisplatin Q3W for four 21-day cycles.
• Pemetrexed — DRUG
  Participants will receive IV pemetrexed Q3W.

Study Details

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).

Key Dates

Start date

Jun 20, 2023

Status verified

May 2026

Primary completion

Jan 29, 2032

Completion

Jan 29, 2032

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A - Combination Dose Finding + Dose Expansion
  Participants will be enrolled in different cohorts to receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W). During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
• Experimental: Cohort B - Combination Dose Finding + Dose Expansion
  Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
• Experimental: Cohort C - Dose Expansion
  Participants enrolled in this cohort will receive one dose level of divarasib QD.
• Experimental: Cohort D - Dose Expansion
  Participants enrolled in this cohort will receive one dose level of divarasib QD.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 5 years) ]

Central Contacts

• Reference Study ID Number: BO44426 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]

Locations (16)

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