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
- Beijing, Changchun, Chengdu, Foshan, Guangzhou, Hangzhou, HangzhouZhejiang, Hefei, Jinan, Nanchang, Nanjing, Shenzhen, Suzhou, Taizhou, and Tianjin, ChinaSee the 17 sites
- Phase
- Phase 3
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 China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Sichuan Cancer HospitalChengdu, ChinaTaking people
- The First People's Hospital of FoshanFoshan, ChinaTaking people
- Guangdong General HospitalGuangzhou, ChinaTaking people
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun CampusHangzhou, ChinaNot yet recruiting
- The Second Affiliated Hospital of Zhejiang University CollegeHangzhouZhejiang, ChinaTaking people
- Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)Hefei, ChinaTaking people
- Cancer Hospital of Shandong First Medical UniversityJinan, ChinaTaking people
- Shandong Provincial HospitalJinan, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTaking people
- Nanjing First HospitalNanjing, ChinaTaking people
- Shenzhen People's HospitalShenzhen, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaTaking people
- Tianjin Cancer HospitalTianjin, ChinaTaking 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.