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Study Comparing Divarasib, Sotorasib, and Adagrasib for Patients with Advanced or Metastatic KRAS G12C-Positive Non-Small Cell Lung Cancer

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

This clinical trial is focused on studying a type of lung cancer known as KRAS G12C-positive advanced or metastatic non-small cell lung cancer. This is a form of lung cancer that has a specific genetic mutation called KRAS G12C, which can make the cancer more challenging to treat. The study is comparing the effectiveness and safety of a new treatment called divarasib against two existing treatments, sotorasib and adagrasib. These treatments are designed to target the KRAS G12C mutation and are taken as film-coated tablets.

The purpose of the study is to evaluate how well these treatments work in preventing the cancer from getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to receive either divarasib, sotorasib, adagrasib, or a placebo. The study will monitor the participants over a period of time to see how the treatments affect their cancer and overall health. This includes looking at how long the treatments can keep the cancer from progressing and any side effects that may occur.

Throughout the study, participants will have regular check-ups and tests to assess their health and the status of their cancer. The study aims to provide valuable information on the best treatment options for patients with KRAS G12C-positive advanced or metastatic non-small cell lung cancer, potentially leading to improved outcomes for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the effectiveness of divarasib compared to other treatments like sotorasib or adagrasib for a specific type of lung cancer.

    The patient will be required to provide a tumor tissue sample to confirm the presence of a KRAS G12C mutation.

  2. Step 2

    Treatment assignment

    The patient will be randomly assigned to receive either divarasib, sotorasib, or adagrasib.

    All medications are administered orally in the form of film-coated tablets.

  3. Step 3

    Medication administration

    If assigned to LUMYKRAS (sotorasib), the patient will take 120 mg tablets.

    If assigned to KRAZATI (adagrasib), the patient will take 200 mg tablets.

    The specific dosage and frequency will be determined by the study protocol and communicated to the patient.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health will be monitored regularly to assess the effectiveness of the treatment.

    Progression-free survival, overall survival, and response to treatment will be evaluated.

    The patient will undergo regular health checks, including vital signs, ECG, and laboratory tests.

  5. Step 5

    Reporting symptoms

    The patient will be asked to report any symptoms or side effects experienced during the trial.

    Common symptoms to report include diarrhea, nausea, vomiting, and others as specified in the study protocol.

  6. Step 6

    Completion of the trial

    The trial is expected to continue until September 2028.

    Upon completion, the patient's overall health and response to the treatment will be evaluated.

Who can join the trial?

10 criteria

  • The patient must have a type of lung cancer called KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
  • The cancer must be measurable according to a specific guideline called RECIST v1.1, which is a way to measure how the cancer responds to treatment.
  • The patient must have a confirmed presence of a KRAS G12C mutation, which is a specific change in the cancer cells, verified through a lab test.
  • The patient must have a test to check for a KEAP1 mutation, which is another specific change in the cancer cells, using a special lab test approved by the study sponsor.
  • The patient must provide a sample of their tumor, either in a block of tissue or as a set of slides, along with a report from a pathologist.
  • The patient must have a negative HIV test, meaning they do not have the HIV virus.
  • The patient must have a negative hepatitis B test, meaning they do not have the hepatitis B virus.
  • The patient must have a negative hepatitis C test, meaning they do not have the hepatitis C virus.
  • The patient must have adequate blood and organ function, which means their blood and organs are working well enough, as checked within 14 days before starting the study treatment.
  • The study is open to both male and female patients.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than **KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot participate.
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Investigated drugs

  • Divarasib

    is a medication being studied for its effectiveness in treating advanced or metastatic non-small cell lung cancer that has a specific genetic mutation known as KRAS G12C. This medication is being compared to other treatments to see if it can help patients live longer without their cancer getting worse.

  • Sotorasib

    is a medication used to treat non-small cell lung cancer with the KRAS G12C mutation. It works by targeting and inhibiting the activity of the mutated KRAS protein, which is involved in the growth and spread of cancer cells.

  • Adagrasib

    is another treatment option for non-small cell lung cancer with the KRAS G12C mutation. Like sotorasib, it targets the KRAS protein to help stop the cancer from growing and spreading. This study is comparing its effectiveness to divarasib.

What is already known about the treatment

  • Divarasib

    Divarasib is administered orally and is currently being evaluated in clinical trials for its effectiveness in treating KRAS G12C-positive advanced or metastatic non-small cell lung cancer (NSCLC). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for divarasib is targeting specific mutations in lung cancer cells. At the molecular level, divarasib works by inhibiting the KRAS G12C protein, which is involved in cell growth and division, thereby slowing down or stopping the progression of cancer. It is classified as a targeted cancer therapy.

  • Sotorasib

    Sotorasib is an oral medication that has been approved for use in treating KRAS G12C-positive advanced or metastatic non-small cell lung cancer (NSCLC). It is recognized in medical literature as a significant advancement in targeted cancer therapy. The primary therapeutic indication for sotorasib is to treat lung cancer with specific genetic mutations. Its mechanism of action involves inhibiting the KRAS G12C protein, which plays a role in cancer cell proliferation, thus helping to control the disease. Sotorasib is classified as a targeted therapy for cancer.

  • Adagrasib

    Adagrasib is taken orally and is currently being studied in clinical trials for its potential to treat KRAS G12C-positive advanced or metastatic non-small cell lung cancer (NSCLC). It is not yet fully established in medical practice, as research is ongoing. The main therapeutic use of adagrasib is to target specific genetic mutations in lung cancer. At the molecular level, adagrasib functions by inhibiting the KRAS G12C protein, which is crucial for cancer cell growth, thereby aiming to reduce tumor progression. It falls under the category of targeted cancer therapies.

Investigated diseases

KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer characterized by a specific genetic mutation in the KRAS gene, known as G12C. It primarily affects the cells lining the lungs and is classified as non-small cell, which is the most common type of lung cancer. The disease is considered advanced or metastatic when it has spread beyond the lungs to other parts of the body. As the cancer progresses, it can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The presence of the KRAS G12C mutation can influence the behavior of the cancer and its response to certain treatments. Understanding the mutation is crucial for developing targeted therapies aimed at slowing the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510908-37-00Protocol codeBO45217Estimated enrolment328 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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