A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

Purpose

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.

Condition

  • Non-small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Divarasib 		Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days).
  • Drug: Divarasib
    Divarasib will be administered orally as per the schedule specified in the respective arm.
    Other names:
    • RO743584; GDC-6036
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.
  • Drug: 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).
    Other names:
    • Keytruda
  • Drug: 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).
    Other names:
    • Opdivo

Recruiting Locations

Community Cancer Institute (CCI)
Clovis, California 93611

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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