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NCT Number: NCT07541170

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)

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Divarasib

Drug

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

Other names: RO743584; GDC-6036

Pembrolizumab

Drug

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

Nivolumab

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From date of randomization to death from any cause (up to approximately 8 years)

  2. DFS Rates at 2 and 3 Years, as Assessed by the Investigator

    Time frame: At Year 2 and Year 3

  3. Number of Participants With Adverse Events (AEs)

    Time frame: From randomization to 60 days after the end of study treatment (up to approximately 8 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S. only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer

Acronym: KRASCENDO 3

Important dates

Study start
2026
Primary completion
2032
Study completion
2035
First posted
Apr 21, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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