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Taking people in JapanPhase 3

Divarasib After Surgery for KRAS G12C-Positive Non-Small Cell Lung Cancer

Tests divarasib against immunotherapy or observation in adults after lung cancer surgery.

Key facts

Who runs it
Hoffmann-La Roche
Where
Gifu, Hiroshima, Hyōgo, and Ōita, JapanSee the 4 sitesAlso in 20 other countries, 142 sites
Trial code
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)
Status
Recruiting
Phase
Phase 3
People taking part
400 people, planned
Started
6 Oct 2026
Expected to end
31 Mar 2035
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Divarasib
  • Pembrolizumab
  • Nivolumab
Record updated
9 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Japan

Also in 20 other countries, 142 sites

  • Gifu University HospitalGifu, JapanTaking people
  • Hiroshima University HospitalHiroshima, JapanTaking people
  • Kobe University HospitalHyōgo, JapanTaking people
  • Oita University HospitalŌita, JapanTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • DivarasibTreatment being tested

    Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days).

  • Control: Pembrolizumab or Nivolumab or ObservationExisting treatment, for comparison

    Participants will receive either pembrolizumab, nivolumab, or undergo observation, depending on the treatment received prior to surgery. No study treatment will be given to participants who will undergo observation.

    Treatment: Pembrolizumab and Nivolumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Divarasib After Surgery for KRAS G12C-Positive Non-Small Cell Lung CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 10 November 2026.
Fit questions
Built from NCT07541170, who can take part
Record updated
9 November 2026