Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Divarasib for Non-small Cell Lung Cancer

The main purpose of this study is to measure the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07541170 · Hoffmann-La Roche · enrollment listed as 400

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Divarasib, Pembrolizumab, or Nivolumab. The registry lists allocation as randomized. The main purpose of this study is to measure the how well it works 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.

They plan to enroll about 400 people at 104 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Divarasib, Pembrolizumab, Nivolumab

Primary outcome (registry wording): Disease-free Survival (DFS), as Determined by the Investigator

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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 randomly assigned within 12 weeks of their surgery date
  • No evidence of disease recurrence or metastatic disease
  • Documentation of the presence of a KRAS G12C mutation

Public study contact (from the registry)

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

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

104 listed

+ 94 sites outside the US on the same record

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NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT07541170 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07541170?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07541170?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary