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Study on JDQ443 and Docetaxel for Patients with Advanced KRAS G12C Mutant 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 non-small cell lung cancer that has a specific mutation called KRAS G12C. The study is comparing the effectiveness and safety of a new medication, referred to as JDQ443, with an existing treatment called docetaxel. Participants in the study have previously received treatment for their cancer, which is either locally advanced or has spread to other parts of the body.

The purpose of the study is to see how well JDQ443 works compared to docetaxel in controlling the cancer. Participants will receive either JDQ443 in tablet form or docetaxel through an intravenous infusion, which means it is given directly into a vein. Some participants may also receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will monitor how long the cancer stays under control and will also look at overall survival rates, which means how long participants live after starting the treatment.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects they might experience. The study will also collect information on how the treatments affect symptoms like chest pain, coughing, and shortness of breath. The trial is expected to continue until the end of 2025, and the results will help determine if JDQ443 is a better option for treating this type of lung cancer compared to the current standard treatment with docetaxel.

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

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of the KRAS G12C mutation in non-small cell lung cancer through laboratory tests.

    Eligibility criteria include being 18 years or older, having received 1 to 3 previous treatments, and having an ECOG performance status between 0 and 2.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either JDQ443 or docetaxel. This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    For those receiving docetaxel, the medication is administered intravenously. The specific dosage and frequency are determined by the study protocol.

    Participants receiving JDQ443 take the medication orally in tablet form. The dosage and frequency are specified in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes evaluating progression-free survival and overall survival.

    Participants undergo routine checks for adverse events, changes in laboratory values, vital signs, and ECGs. Quality of life assessments are also performed using specific questionnaires.

  5. Step 5

    End of treatment

    The study continues until the estimated end date in December 2025, or until specific endpoints are reached.

    Upon completion, participants may undergo a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

4 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants must have a type of lung cancer called non-small cell lung cancer that is advanced and has a specific change in the cancer cells known as the KRAS G12C mutation. This must be confirmed by a test done in a lab using tissue or blood samples.
  • Participants must have already received between 1 and 3 different treatments for their cancer. This includes at least one treatment with a type of drug called platinum-based chemotherapy and one treatment with a checkpoint inhibitor, which helps the immune system fight cancer.
  • Participants must have an ECOG performance status of 0 to 2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 meaning the person is up and about more than half the day but may not be able to work.

Who cannot join the trial?

5 criteria

  • Patients who do not have advanced non-small cell lung cancer with a specific change in their genes called the KRAS G12C mutation cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
  • Patients who are considered part of a vulnerable population, meaning they might need special protection or care, cannot participate.
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Investigated drugs

  • JDQ443

    is an investigational medication being studied for its potential to treat non-small cell lung cancer that has a specific genetic mutation known as KRAS G12C. This medication is being tested to see if it can help stop the cancer from growing or spreading in patients who have already received other treatments.

  • Docetaxel

    is a chemotherapy drug that is commonly used to treat various types of cancer, including lung cancer. It works by interfering with the growth and division of cancer cells, which can help to slow down or stop the progression of the disease. In this trial, it is being used as a comparison to evaluate the effectiveness of JDQ443.

What is already known about the treatment

  • JDQ443

    JDQ443 is an investigational medication administered orally, currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer with the KRAS G12C mutation. It is not yet approved for general medical use, as it is still under investigation in phase III clinical trials. The main therapeutic indication for JDQ443 is to improve progression-free survival in patients with this specific type of lung cancer. At the molecular level, JDQ443 works by selectively inhibiting the KRAS G12C protein, which is involved in cell growth and division, thereby potentially slowing down or stopping the growth of cancer cells. JDQ443 is classified as a targeted cancer therapy.

  • Docetaxel

    Docetaxel is a chemotherapy medication administered intravenously, widely used and approved for the treatment of various cancers, including non-small cell lung cancer. It is a well-established treatment option and is being used as a comparator in clinical trials to evaluate new therapies. The main therapeutic indication for docetaxel is to treat advanced or metastatic cancers by disrupting the normal function of microtubules, which are essential for cell division, leading to cancer cell death. Docetaxel is classified as a taxane-based chemotherapy agent.

Investigated diseases

Advanced Non-Small Cell Lung Cancer Harboring the KRAS G12C Mutation – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by the presence of a specific genetic mutation known as KRAS G12C. It is classified as "non-small cell" because the cancer cells are larger than those found in small cell lung cancer. The disease typically progresses by spreading to nearby tissues and potentially to other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and general health decline. The presence of the KRAS G12C mutation can influence the behavior of the cancer and its response to certain treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510082-10-00Protocol codeCJDQ443B12301Estimated enrolment248 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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