Divarasib vs investigator’s choice of immunotherapy or observation after resection in KRAS G12C NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 trial comparing divarasib to an investigator’s choice of pembrolizumab, nivolumab, or observation in adults with Stage II-IIIB KRAS G12C-positive NSCLC who have had a complete surgical resection but not a pathologic complete response after neoadjuvant chemoimmunotherapy. Participants are randomized within 12 weeks of surgery and must have no detectable disease. The study will evaluate whether divarasib improves outcomes compared with the chosen standard-of-care options or no additional therapy. Safety and efficacy data will be collected to determine potential benefit and risks of continuing targeted therapy in the adjuvant setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Community Cancer Institute (CCI)
  Clovis, California, United States Recruiting
• Bay Pines VA Healthcare System
  Bay Pines, Florida, United States Recruiting
• Piedmont Cancer Institute, PC
  Atlanta, Georgia, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Profound Research, LLC
  Farmington Hills, Michigan, United States Recruiting
• Renown Regional Medical Center
  Reno, Nevada, United States Recruiting

+54 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.