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Study of Adagrasib with Pembrolizumab and Chemotherapy for Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

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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 treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) in patients who have a specific genetic change called the KRAS G12C mutation. The study will explore the effectiveness of a new treatment combination that includes Adagrasib, a medication taken orally, along with Pembrolizumab, which is given through an infusion into a vein, and chemotherapy. The purpose of the study is to evaluate how well this combination works as a first-line treatment for patients with this type of lung cancer.

Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will look at how the cancer responds to the treatment, how long the response lasts, and any side effects that may occur. The study will also measure the levels of Adagrasib in the body to understand how it is processed. The trial aims to provide valuable information on the safety and effectiveness of this treatment combination for patients with Advanced Non-Small Cell Lung Cancer with the KRAS G12C mutation.

The study is expected to continue until early 2028, with recruitment of participants starting in late 2024. This trial is an important step in finding new and effective treatments for patients with this specific type of lung cancer, potentially offering new hope for those affected by this condition.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient will be required to provide consent to participate in the trial.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with adagrasib in combination with pembrolizumab and chemotherapy. The specific chemotherapy drugs used may include pemetrexed, carboplatin, and cisplatin.

  4. Step 4

    Medication administration

    The patient will receive adagrasib orally. Pembrolizumab and chemotherapy drugs will be administered intravenously. The frequency and dosage will be determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    The patient will be monitored regularly for response to treatment and any side effects. This includes regular blood tests and imaging studies to assess the cancer's response.

  6. Step 6

    Evaluation of response

    The patient's response to the treatment will be evaluated using criteria such as the objective response rate and progression-free survival.

  7. Step 7

    Completion of treatment

    Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response and any long-term effects.

  8. Step 8

    Long-term follow-up

    The patient may be required to participate in long-term follow-up to monitor for any delayed side effects and to assess the duration of response.

Who can join the trial?

5 criteria

  • The patient must have a confirmed diagnosis of **advanced non-small cell lung cancer**. This means the cancer is in the lungs and has either spread to other parts of the body or cannot be removed by surgery.
  • The cancer must have a specific genetic change called the **KRAS G12C mutation**. This is a change in the DNA of the cancer cells that can affect how the cancer grows.
  • The patient must be at least 18 years old. This means they must be an adult.
  • Both **men and women** can participate in the study.
  • The study is open to people who may be considered part of a **vulnerable population**. This term refers to groups of people who might need special protection or care, such as those with certain health conditions or social situations.

Who cannot join the trial?

5 criteria

  • Patients who do not have Advanced Non-Small Cell Lung Cancer cannot participate. This is a type of lung cancer that is more advanced.
  • Patients who do not have the KRAS G12C mutation cannot participate. This is a specific change in the cancer's genetic material.
  • Patients who are not within the specified age range cannot participate. The study is for adults.
  • Patients who are not able to receive the combination of adagrasib, pembrolizumab, and chemotherapy cannot participate. These are specific treatments used in the study.
  • Patients who are part of a vulnerable population that the study does not include cannot participate. This means groups of people who might need special protection.
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Investigated drugs

  • Adagrasib

    is a medication being studied for its potential to treat advanced non-small cell lung cancer (NSCLC) in patients with a specific genetic mutation known as KRAS G12C. It works by targeting and inhibiting the activity of the KRAS G12C protein, which is involved in the growth and spread of cancer cells.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is used in combination with other treatments to enhance the immune response against cancer.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside other treatments to improve the overall effectiveness against advanced non-small cell lung cancer.

What is already known about the treatment

Adagrasib – Adagrasib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer (NSCLC) with a specific genetic mutation known as KRAS G12C. The medication works by specifically targeting and inhibiting the KRAS G12C protein, which is involved in the growth and survival of cancer cells. Adagrasib is classified as a targeted cancer therapy, focusing on molecular changes that are specific to cancer cells.

Investigated diseases

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its non-small cell nature, which means the cancer cells are larger than those found in small cell lung cancer. It is considered advanced when it has spread beyond the lungs to other parts of the body. The disease progresses as the cancer cells grow and divide uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs, leading to further complications. The progression can vary significantly among individuals, depending on factors like genetic mutations and overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503714-77-00Protocol code849-017Estimated enrolment137 patientsSponsorMirati Therapeutics Inc.

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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).