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)

Cancer
Lung Cancer
Non Small Cell Lung Carcinoma

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT07541170, BO45885, 2025-524263-21-00

Condition Non-small Cell Lung Cancer

Official 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

Study 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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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)

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

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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)

For the latest version of this information please go to www.forpatients.roche.com