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Comparison of Sotorasib versus Docetaxel in Previously Treated Non-Small Cell Lung Cancer Patients with KRAS p.

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 study focuses on patients with non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body (metastatic), and specifically has a certain genetic change called KRAS p.G12C mutation. The study compares two treatments: sotorasib (also known as AMG 510), which is taken as tablets by mouth, and docetaxel, which is given through an infusion into a vein. Patients may also receive dexamethasone, a medication that helps manage side effects.

The main goal of this research is to determine if sotorasib works better than docetaxel in treating this specific type of lung cancer. The study will measure how long the cancer can be controlled before it starts growing again and how long patients live with either treatment. During the study, doctors will also track changes in cancer-related symptoms such as breathing problems, coughing, and chest pain.

Throughout the study, patients will have regular medical check-ups and imaging tests to monitor their cancer. The research team will evaluate how well each treatment works by looking at changes in tumor size and watching for signs that the cancer is growing or spreading. They will also assess how the treatments affect patients' daily activities and overall well-being.

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

    You will undergo an assessment to confirm your eligibility for the study. This includes verification that you are at least 18 years old and have non-small cell lung cancer with a specific genetic change called KRAS p.G12C mutation.

    Your ability to perform daily activities will be evaluated using a scale called ECOG, which must show a score of 1 or better.

  2. Step 2

    Random assignment to treatment group

    You will be randomly assigned to receive either sotorasib tablets taken by mouth or docetaxel given through an intravenous infusion.

    If assigned to the docetaxel group, you will also receive dexamethasone tablets as part of your treatment.

  3. Step 3

    Treatment period

    Your treatment will be organized in cycles, during which you will receive either sotorasib or docetaxel.

    Regular assessments will be performed to monitor how your cancer responds to the treatment.

    Imaging scans will be reviewed by independent specialists to evaluate any changes in your condition.

  4. Step 4

    Health monitoring

    Your symptoms will be regularly assessed, focusing on breathing difficulties, coughing, and chest pain.

    Your overall physical functioning and health status will be evaluated, particularly during the first 12 weeks of treatment.

    Regular medical examinations and tests will be conducted to monitor your response to treatment.

  5. Step 5

    Study completion

    The study will continue until either your disease progresses or other factors determine the end of your participation.

    The overall study is expected to continue until April 2027.

    Your health status will continue to be monitored even after completing the active treatment phase.

Who can join the trial?

7 criteria

  • Age: Must be 18 years or older
  • Must have a KRAS p.G12C mutation (a specific genetic change in lung cancer cells) confirmed through central testing or previous documentation from Amgen Study 20190294
  • Must have non-small cell lung cancer (NSCLC) that is:
    • Locally advanced and cannot be surgically removed (unresectable), or
    • Has spread to other parts of the body (metastatic)
    • Must have received previous treatment for lung cancer
    • Must have an ECOG score of 0 or 1 (a measure of physical ability where 0 means fully active and 1 means restricted in physically strenuous activity but able to walk and do light work)
    • Both men and women can participate

Who cannot join the trial?

12 criteria

  • History of prior treatment with any KRAS G12C inhibitor (medications targeting a specific gene mutation)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • Known active infection requiring systemic therapy (infection needing medication that affects the whole body)
  • History of other cancer within the last 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart problems, including: - Heart attack within the past 6 months - Unstable angina (chest pain) - Heart failure requiring treatment
  • Severe liver problems or abnormal liver function tests
  • Known allergy or sensitivity to study medications
  • Pregnant or breastfeeding women
  • Any condition that would make it unsafe to participate in the study, as determined by the study doctor
  • Current participation in other clinical trials or use of investigational drugs within 28 days before starting this study
  • Unable to swallow oral medications
  • Major surgery within 28 days before starting the study
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Investigated drugs

  • AMG 510

    is an investigational medication designed to target specific mutations in lung cancer cells, particularly those with KRAS p.G12C mutation. It is being studied as a potential treatment for non-small cell lung cancer (NSCLC) in patients who have previously received other treatments.

  • Docetaxel

    is a chemotherapy medication commonly used to treat various types of cancer, including non-small cell lung cancer. It works by interfering with cell division, which helps to stop or slow down the growth of cancer cells. This medication is being used as the comparison treatment in this study.

What is already known about the treatment

  • AMG 510

    An investigational targeted therapy medication specifically designed for treating non-small cell lung cancer (NSCLC) with KRAS p.G12C mutation. This drug is being studied in patients with locally advanced and unresectable or metastatic NSCLC who have received previous treatment. It works by specifically targeting and inhibiting the KRAS G12C protein mutation, which is known to drive cancer growth. The medication represents a new approach in precision medicine for lung cancer treatment.

  • Docetaxel

    A widely used chemotherapy medication administered through intravenous infusion for treating various types of cancer, including non-small cell lung cancer. It belongs to the taxane family of drugs and works by disrupting cell division, preventing cancer cells from growing and spreading. This medication has been an established standard treatment option for previously treated advanced NSCLC and serves as the active control in clinical trials comparing new therapeutic approaches.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. It develops when cells in the lungs begin to grow uncontrollably, forming tumors that can spread to nearby tissues. The disease typically progresses gradually, affecting lung function and potentially spreading to other parts of the body. NSCLC specifically with KRAS p.G12C mutation is a distinct molecular subtype where a specific genetic change occurs in the KRAS gene. This form of lung cancer can develop from the cells lining the larger airways and can progress to advanced stages where it becomes locally advanced (spreading to nearby tissues) or metastatic (spreading to distant parts of the body).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508214-42-00Protocol code20190009Estimated enrolment571 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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