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Adjuvant Therapy with RO7435846 (divarasib) versus Pembrolizumab or Nivolumab or Observation in Patients After Surgery for Stage II‑III KRAS G12C NSCLC

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients who have had surgery to remove Non-Small Cell Lung Cancer that was at stage II or III and carries the KRAS G12C mutation, a change in a gene that can help the cancer grow. After surgery, the disease can return, so the trial is testing an oral medication called RO7435846 (divarasib) and comparing it with two already‑approved immunotherapy drugs, pembrolizumab and nivolumab, or with simply watching the patient without further treatment (observation). Immunotherapy is a type of medicine that helps the body’s own immune system fight cancer.

The purpose of the study is to compare how well the new drug works against standard immunotherapy or observation in preventing cancer from coming back. Participants will be randomly placed into one of the three groups, receive the assigned treatment (a daily tablet for the new drug or an intravenous infusion for the immunotherapies), and then be monitored with regular doctor visits and imaging scans to check for any signs of the disease returning or new health issues over several years.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study you sign an informed consent form that explains the purpose of the trial and what will be required of you.

  2. Step 2

    Randomization

    The study team assigns you randomly to one of the following groups: divarasib tablets, pembrolizumab intravenous infusion, nivolumab intravenous or subcutaneous injection, or observation without study medication.

  3. Step 3

    Baseline assessments

    Before any treatment begins you undergo medical history review, physical examination, laboratory tests, and imaging scans to document the current status of your cancer.

  4. Step 4

    Start of assigned therapy

    If you are assigned to divarasib, you take an oral film‑coated tablet as directed by the study protocol. the exact dose and schedule are defined by the investigators.

    If you are assigned to pembrolizumab, you receive an intravenous infusion at the clinic according to the schedule set by the study protocol.

    If you are assigned to nivolumab, you receive either an intravenous infusion or a subcutaneous injection as directed by the study protocol.

    If you are assigned to observation, you do not receive any study medication but you attend regular clinic visits for monitoring.

  5. Step 5

    Regular clinic visits and safety monitoring

    You return to the clinic at intervals specified in the protocol to receive your medication (or to have a check‑up if you are in the observation group). during each visit the study staff checks for side effects, records any adverse events, and may perform laboratory tests.

  6. Step 6

    Periodic disease evaluation

    At scheduled times you undergo imaging scans and clinical examinations to assess whether the cancer has returned. this evaluation contributes to the measurement of disease‑free survival (the time from randomization until cancer recurrence or death).

  7. Step 7

    Continuation of therapy

    You continue taking the assigned medication or attending observation visits until one of the following occurs: the cancer returns, side effects become unacceptable, or the study reaches its planned end date.

  8. Step 8

    Final follow‑up and study completion

    After treatment stops, you have a final follow‑up visit where overall survival (the time from randomization until death from any cause) and long‑term safety are recorded. the study then closes for your participation.

Who can join the trial?

6 criteria

  • KRAS G12C mutation must be confirmed in your tumor tissue. This is a specific genetic change that can affect how the cancer behaves.
  • Your overall health must be rated as ECOG Performance Status 0 or 1. This means you are fully active (0) or able to carry out light work (1) without being bedridden.
  • You need a diagnosis of stage II to stage IIIB non‑small cell lung cancer (NSCLC) based on a tissue or cell test (histology or cytology) and it can be either squamous or non‑squamous type.
  • You must have had a complete surgical removal (resection) of the lung cancer, meaning all visible tumor was taken out.
  • You must have previously received neoadjuvant immune checkpoint inhibitor therapy (such as pembrolizumab or nivolumab) together with a platinum‑based doublet chemotherapy regimen. “Neoadjuvant” means the treatment was given before surgery, and “immune checkpoint inhibitor” is a drug that helps your immune system attack cancer.
  • There must be no signs of cancer returning or spreading (no recurrence or metastatic disease) at the time of enrollment.

Who cannot join the trial?

5 criteria

  • Having taken a KRAS inhibitor (a drug that blocks a specific gene change) or any other anti‑cancer therapy not listed in the study plan before joining the trial.
  • Having received radiation therapy for NSCLC (non‑small cell lung cancer), except for a small, symptom‑focused radiation given before the tumor‑removing surgery (localized symptom‑directed radiation prior to surgical resection).
  • If the cancer disappears completely after treatment given before surgery (pCR – pathologic complete response after neoadjuvant treatment).
  • If you have had a severe immune‑related side effect (Grade 3 or higher) that is still resolved, or a moderate or worse immune‑related side effect (Grade 2 or higher) that has not resolved, from the treatment given before surgery (neoadjuvant immunotherapy).
  • If you received a live, attenuated vaccine (a vaccine with a weakened form of the germ) within 4 weeks before being placed into a study group (randomization), or if you might need such a vaccine while on the study drug or within 5 months after the last dose of the study drug.
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Investigated drugs

  • Divarasib

    is an oral medication taken as a film‑coated tablet. In this study it is the new drug being tested to see if it can keep cancer from coming back after surgery. It works by blocking a specific protein that helps cancer cells grow, so researchers hope it will improve the time patients stay free of disease.

  • Pembrolizumab

    is an immunotherapy given by injection (either into a vein or under the skin). It helps the body’s immune system recognize and attack cancer cells. In the trial it is one of the standard treatments that the new drug is compared against.

  • Nivolumab

    is another immunotherapy given by injection. Like pembrolizumab, it boosts the immune system’s ability to find and destroy cancer cells. It is also used as a comparator to see how well the new drug works.

  • Observation

    means that patients do not receive any additional medication after surgery. Instead, they are closely monitored with regular check‑ups and tests to see if the cancer returns. This approach is included in the study as a reference point for how patients do without further treatment.

What is already known about the treatment

  • Nivolumab

    Nivolumab is given by a slow intravenous infusion, allowing the drug to enter the bloodstream directly. It is an approved cancer medicine and is widely described in medical literature as a PD‑1 immune‑checkpoint inhibitor. It is used mainly for treating non‑small cell lung cancer and several other tumors. The drug works by attaching to the PD‑1 protein on immune cells, stopping it from turning off the body's attack on cancer, and it belongs to the class of monoclonal antibody immunotherapies.

  • Pembrolizumab

    Pembrolizumab is administered through an intravenous infusion that delivers the medication straight into the blood. It is a fully approved therapy and is well documented as a PD‑1 blocking antibody for many cancers, including lung cancer. Its main use is to help the immune system recognize and fight tumor cells in non‑small cell lung cancer and other malignancies. It works by binding to the PD‑1 receptor on T‑cells, preventing the cancer from disabling the immune response, and is classified as a monoclonal antibody immunotherapy.

  • Divarasib

    Divarasib is taken as an oral film‑coated tablet, which is swallowed and absorbed through the gut. It is still an investigational drug and is currently being studied in clinical trials for KR RAS G12C‑positive lung cancer. The medication is designed to treat non‑small cell lung cancer that carries the KRAS G12C mutation. It works by locking the mutant KRAS protein in an inactive form, stopping it from sending growth signals to cancer cells, and it is classified as a KRAS G12C inhibitor, a type of targeted therapy.

Investigated diseases

Resected stage II–III KRAS G12C‑positive non‑small cell lung cancer - This disease is a form of lung cancer that begins in the cells lining the airways and is classified as non‑small cell type. It carries a specific KRAS G12C genetic alteration that can influence how the cancer cells grow. Patients have undergone surgical removal of the tumor and are classified as stage II or III, indicating spread to nearby lymph nodes or structures. After surgery, any remaining cancer cells may slowly increase in number and can reappear at the original site or in other parts of the body. The disease can progress from local recurrence to involvement of distant organs over time.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524263-21-01Protocol codeBO45885Estimated enrolment400 patientsSponsorF. Hoffmann-La Roche AG

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