Recruiting
Phase 3

Divarasib vs. Immunotherapy

Sponsor:

Hoffmann-La Roche

Code:

NCT07541170

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Divarasib

Pembrolizumab

Nivolumab

Study Details

Brief summary:

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

Study ID

NCT07541170

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Mar 31, 2035

Anticipated

Primary completion date

Jan 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
  • Participants must have had complete resection of NSCLC
  • Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
  • Participants must be randomized within 12 weeks of their surgery date
  • No evidence of disease recurrence or metastatic disease
  • Documentation of the presence of a KRAS G12C mutation

Exclusion Criteria:

  • Participants who achieve pCR following neoadjuvant treatment
  • Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
  • Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
  • Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy
  • Active or history of autoimmune disease or immune deficiency
  • Significant cardiovascular disease

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Divarasib

Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days).

active comparator: Control: Pembrolizumab or Nivolumab or Observation

Participants will receive either pembrolizumab, nivolumab, or undergo observation, depending on the treatment received prior to surgery. No study treatment will be given to participants who will undergo observation.

Interventions

Divarasib

Divarasib will be administered orally as per the schedule specified in the respective arm.

Pembrolizumab

Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days).

Nivolumab

Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days).

Primary outcome measure

  • Disease-free Survival (DFS), as Determined by the Investigator [ Time Frame: From randomization to disease recurrence or death from any cause (Up to approximately 5 years) ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. only)global-roche-genentech-trials@gene.com

Locations

Community Cancer Institute (CCI)

Recruiting

Clovis, California, United States, 93611

Piedmont Cancer Institute, PC

Recruiting

Atlanta, Georgia, United States, 30318

Profound Research, LLC

Recruiting

Farmington Hills, Michigan, United States, 48334

Cancer Care Specialists

Recruiting

Reno, Nevada, United States, 89511

San Juan Oncology Associates

Recruiting

Farmington, New Mexico, United States, 87401

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-09.