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RecruitingPhase 3

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)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well divarasib works and how safe it is compared with immune therapy (pembrolizumab or nivolumab) or watching without treatment. It is for people with stage II–IIIB non-small cell lung cancer with a KRAS G12C gene change who had surgery after chemotherapy and immune therapy, but still had cancer cells in the removed tissue.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can do most daily tasks, with no limits or only limits on hard physical activity.
  • Lab tests confirmed stage II–IIIB non-small cell lung cancer.
  • You had surgery to fully remove the lung cancer.
  • Before surgery, you received pembrolizumab or nivolumab plus a two-drug chemotherapy treatment that included platinum.
  • You must be assigned to a study group within 12 weeks after surgery.
  • There is no sign that the cancer has come back or spread to distant parts of the body.
  • Tests show that your cancer has a KRAS G12C gene change.

Who can't join

  • No cancer cells were found in the tissue removed during surgery after treatment.
  • You previously took a drug that blocks KRAS or another cancer treatment not allowed by the study plan.
  • You had radiation for this lung cancer, unless it was aimed at a small area to ease symptoms before surgery.
  • Immune therapy before surgery caused severe immune-related side effects that have gone away, or moderate or worse side effects that have not gone away.
  • You have or have had an autoimmune disease, where the immune system attacks the body, or an immune system deficiency.
  • You have a serious heart or blood vessel disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (6)

CA

GA

MI

NM

NV