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Study of divarasib and pembrolizumab compared to standard chemotherapy in previously untreated KRAS G12C-mutated advanced non-small cell lung cancer

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What is this trial about?

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

This study focuses on Non-Small Cell Lung Cancer that is advanced or has spread to other parts of the body (metastatic), specifically in patients who have not received previous treatment and whose cancer has a specific genetic change called KRAS G12C mutation. The study will test a combination of medications including divarasib (also known as GDC-6036) and pembrolizumab (KEYTRUDA) compared to a combination of pembrolizumab with pemetrexed and either carboplatin or cisplatin.

The study aims to determine whether the combination of divarasib and pembrolizumab works better than the standard treatment combination in treating this type of lung cancer. The medications will be given through different routes - divarasib as tablets taken by mouth, while pembrolizumab, pemetrexed, carboplatin, and cisplatin are given through an intravenous infusion (through a vein).

During the study, doctors will monitor how the cancer responds to treatment and track any side effects that may occur. They will also assess how the treatment affects patients' quality of life and symptoms related to their cancer, such as cough and breathing difficulties. The study will measure how long patients live without their cancer getting worse and their overall survival time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be confirmed based on specific criteria, including having advanced or metastatic non-squamous non-small cell lung cancer that cannot be treated with surgery.

    A test will confirm the presence of a specific genetic mutation called KRAS G12C in your tumor or blood sample.

    Your physical condition will be evaluated using the ECOG Performance Status scale, which must be 0 or 1.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Treatment with divarasib (oral tablets) and pembrolizumab (intravenous infusion)

    Group 2: Treatment with pembrolizumab, pemetrexed, and either carboplatin or cisplatin (all given as intravenous infusions)

  3. Step 3

    Treatment period

    Your treatment will be given in cycles

    Regular assessments will monitor your response to treatment using imaging scans

    Blood tests and physical examinations will be conducted to monitor your health

    You will complete quality of life questionnaires about your symptoms and daily functioning

  4. Step 4

    Monitoring period

    Your health status will be regularly monitored through physical examinations

    Side effects will be tracked using standardized criteria

    The effectiveness of the treatment will be measured by tracking how your disease responds

    Quality of life assessments will continue throughout the study

  5. Step 5

    Study completion

    The study is expected to continue until December 2030

    Your participation duration will depend on how your disease responds to treatment and any side effects you may experience

Who can join the trial?

9 criteria

  • Must have non-squamous non-small cell lung cancer (a type of lung cancer) that is advanced or has spread to other parts of the body, and has not been previously treated
  • Must have a KRAS G12C mutation (a specific genetic change) confirmed through testing of tumor tissue or blood sample
  • Must have cancer that can be measured using standard imaging methods (RECIST v1.1 criteria)
  • Must have good physical function, with an ECOG Performance Status of 0 or 1 (ability to perform daily activities with minimal assistance)
  • Must have a life expectancy of at least 12 weeks
  • Must have cancer that cannot be cured with surgery or radiation therapy combined with chemotherapy
  • Must not have received any previous systemic treatment (medication that travels through the bloodstream) for advanced lung cancer
  • Both men and women may participate in the study
  • Must be an adult (18 years or older)

Who cannot join the trial?

13 criteria

  • Prior treatment with systemic therapy for advanced or metastatic non-small cell lung cancer
  • Known active brain metastases (cancer that has spread to the brain) or spinal cord compression
  • History of other cancer within 3 years before starting the study, except for adequately treated non-melanoma skin cancer or carcinoma in situ
  • Active autoimmune disease requiring systemic treatment within the past 2 years (a condition where the immune system attacks healthy cells)
  • History of severe allergic reactions to monoclonal antibodies (a type of targeted therapy)
  • Active infection requiring systemic therapy
  • Uncontrolled heart conditions including heart failure, irregular heartbeat, or high blood pressure
  • History of pneumonitis (inflammation of lung tissue) requiring steroids
  • Active hepatitis B or C infection
  • Known history of HIV infection
  • Receipt of live vaccine within 30 days prior to starting treatment
  • Pregnant or breastfeeding women
  • Any condition that would interfere with the safety of the participant or the quality of the study data
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Investigated drugs

  • Divarasib

    is a targeted therapy medication designed to treat specific types of lung cancer that have a particular genetic mutation called KRAS G12C. It works by blocking the abnormal protein that causes cancer cells to grow and spread.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system recognize and fight cancer cells. It works by blocking a protein that prevents immune cells from attacking cancer cells, allowing the immune system to work more effectively against the cancer.

  • Pemetrexed

    is a chemotherapy medication that works by stopping cancer cells from making DNA and other molecules they need to grow and multiply. It is commonly used to treat non-small cell lung cancer.

  • Carboplatin

    is a platinum-based chemotherapy medication that works by damaging the DNA of cancer cells, which prevents them from dividing and causes them to die. It is widely used to treat various types of cancer.

  • Cisplatin

    is another platinum-based chemotherapy medication that, like carboplatin, works by damaging cancer cell DNA. It is also commonly used in the treatment of various cancers, including lung cancer.

What is already known about the treatment

  • Divarasib

    An investigational oral medication being studied for the treatment of KRAS G12C-mutated non-small cell lung cancer. This targeted therapy works by specifically inhibiting the KRAS G12C mutation at the molecular level, blocking cancer cell growth and survival signals. It is currently being evaluated in combination with pembrolizumab in phase III clinical trials for previously untreated advanced or metastatic non-squamous non-small cell lung cancer.

  • Pembrolizumab

    An intravenously administered immunotherapy medication that works by helping the immune system detect and fight cancer cells. It belongs to the class of PD-1 inhibitors and functions by blocking the PD-1 pathway, which cancer cells often use to evade immune system detection. This medication is approved for various types of cancer, including non-small cell lung cancer, and is being studied in combination with other therapies.

  • Pemetrexed

    An intravenous chemotherapy medication that belongs to the class of antifolate antineoplastic agents. It works by blocking several enzymes necessary for cancer cell growth and division, particularly in non-squamous non-small cell lung cancer. This medication is commonly used in combination with platinum-based chemotherapy drugs as a standard treatment option for advanced lung cancer.

  • Carboplatin

    An intravenous platinum-based chemotherapy medication that works by binding to and damaging cancer cell DNA, preventing cell division and leading to cell death. It belongs to the platinum compounds class and is commonly used in combination therapy for various types of cancer, including non-small cell lung cancer, with a generally more tolerable side effect profile compared to similar drugs.

  • Cisplatin

    An intravenous platinum-based chemotherapy medication that functions by creating cross-links in DNA, preventing cancer cells from dividing and ultimately causing their death. It belongs to the platinum compounds class and is one of the most widely used chemotherapy drugs, often combined with other medications in the treatment of various cancers, including non-small cell lung cancer.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) - A type of lung cancer that begins in the large cells of the lung, specifically in non-squamous cells. It typically develops slowly and forms in the tissues of the lung, particularly in cells that line the air passages. Non-squamous NSCLC includes adenocarcinoma and large cell carcinoma subtypes. When described as advanced or metastatic, it means the cancer has spread beyond its original location to other parts of the body. This condition often develops without early symptoms, becoming noticeable only in later stages when the tumor has grown larger.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518365-10-00Protocol codeCO45042Estimated enrolment600 patientsSponsorF. Hoffmann-La Roche AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).