Divarasib After Surgery for KRAS G12C-Positive Non-Small Cell Lung Cancer
Tests divarasib against immunotherapy or observation in adults after lung cancer surgery.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Athens, Chaïdári, Larissa, Maroussi, and Thessaloniki, GreeceSee the 7 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose lung cancer (stage II-IIIB non-small cell) was fully removed by surgery, who still had cancer cells after treatment before surgery, and whose tumor has a KRAS G12C mutation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Clinical stage II-IIIB non-small cell lung cancer (non-squamous or squamous). The cancer was completely removed by surgery. No sign of cancer coming back or spreading.
- Earlier treatment
- Must have had treatment before surgery with pembrolizumab or nivolumab plus platinum-based chemotherapy. Must be randomized within 12 weeks of surgery. Cannot have had a KRAS inhibitor or other anti-cancer therapy not named in the protocol.
- Biomarker or test result
- A documented KRAS G12C mutation is required.
Main reasons for not taking part
- Complete pathologic response (no cancer cells left) after treatment before surgery
- Earlier treatment with a KRAS inhibitor or other anti-cancer therapy not named in the protocol
- Earlier radiation therapy for lung cancer, except localized radiation for symptoms before surgery
- Serious immune-related side effect from the treatment before surgery
- Active or past autoimmune disease or immune deficiency
Read by machine on 10 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
Source: NCT07541170, who can take part
Where in Greece
- Henry Dunant Hospital CenterAthens, GreeceTaking people
- Thoracic General Hospital of Athens "I Sotiria"Athens, GreeceTaking people
- University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Chaïdári, GreeceTaking people
- General University Hospital of LarissaLarissa, GreeceTaking people
- Athens Medical Center S.A.Maroussi, GreeceTaking people
- Athens Medical Center S.A.Thessaloniki, GreeceTaking people
- St. Luke's Hospital S.A.Thessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07541170EU 2025-524263-21-01
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Participants who achieve pCR following neoadjuvant treatment.