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Study on JDQ443 for First-Line Treatment in Patients with Advanced KRAS G12C-Mutated Non-Small Cell Lung Cancer

Verified siteInvestigationalNo 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 (NSCLC) that has a specific genetic change called the KRAS G12C mutation. This mutation is found in some patients with advanced stages of NSCLC. The study is testing a new treatment called JDQ443, which is taken as a tablet. JDQ443 is being evaluated as a first-line treatment, meaning it is the first treatment given for this type of cancer.

The purpose of the study is to assess how well JDQ443 works and how safe it is for patients with this specific type of lung cancer. The study will include patients whose cancer has spread locally or to other parts of the body, and who have not received any previous treatment for their advanced cancer. The study will also consider the presence of another genetic factor called PD-L1 expression, which can be either less than 1% or 1% and above, and may include an additional genetic change known as an STK11 co-mutation.

Participants in the study will take JDQ443 orally, and the study will monitor their response to the treatment over time. The study aims to understand the overall response rate, which is the proportion of patients who experience a reduction in their cancer size. It will also look at how long the response lasts, the time it takes for the cancer to progress, and overall survival rates. Additionally, the study will track any side effects or changes in health indicators such as laboratory values and vital signs. The trial is expected to continue until October 2025.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria, including the presence of a KRAS G12C mutation in non-small cell lung cancer (NSCLC) and the ability to swallow medication.

    Participants must have a measurable lesion and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

  2. Step 2

    Treatment initiation

    The treatment involves taking a medication called JDQ443, which is administered orally in the form of a tablet.

    The dosage and frequency of administration are determined by the study protocol and are designed to assess the antitumor activity of JDQ443 as a first-line treatment.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to evaluate the response to treatment. This includes imaging tests to measure tumor size and assess overall response rate (ORR), which is the proportion of participants with a confirmed complete or partial response.

    Additional assessments include monitoring for any side effects, changes in laboratory values, vital signs, and electrocardiograms (ECGs).

  4. Step 4

    Follow-up evaluations

    Participants undergo follow-up evaluations to determine the duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

    These evaluations help in understanding the time from the first response to disease progression or death, and the overall time from enrollment to death.

  5. Step 5

    Completion of study

    The study is estimated to conclude by October 31, 2025. Participants will continue to be monitored until the end of the study or until they meet criteria for discontinuation.

    Final assessments will include a comprehensive review of the treatment's efficacy and safety, as well as any changes in quality of life as measured by specific questionnaires.

Who can join the trial?

10 criteria

  • The patient must have a type of lung cancer called **non-small cell lung cancer (NSCLC)** that is either **locally advanced** (meaning it has spread to nearby areas but not far away) or **metastatic** (meaning it has spread to other parts of the body).
  • The cancer must have a specific genetic change called a **KRAS G12C mutation**.
  • The patient must not have had any previous treatments that affect the whole body for their metastatic cancer. However, if they had treatments like chemotherapy or immunotherapy for earlier stages of cancer, it is okay if it was more than 12 months ago.
  • The patient must have at least one cancer area that can be measured by doctors using a standard method called **RECIST 1.1**.
  • The patient must have a **PD-L1 expression** level, which is a measure of a protein on cancer cells, that is either less than 1% or 1% or more with another genetic change called an **STK11 co-mutation**.
  • The patient must be able to swallow the medication used in the study.
  • The patient must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must be within the age range that includes adults and older adults.
  • Both male and female patients can participate.
  • The study may include people who are considered vulnerable, meaning they might need extra protection or care.

Who cannot join the trial?

5 criteria

  • Patients who do not have a specific type of lung cancer called KRAS G12C-mutated non-small cell lung cancer.
  • Patients whose cancer does not have a PD-L1 expression of less than 1% or greater than or equal to 1% with an STK11 co-mutation. PD-L1 expression is a measure of a protein that can affect how the immune system responds to cancer. An STK11 co-mutation is a change in a specific gene that can occur alongside other mutations.
  • Patients who are not in the age range specified for the study.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

JDQ443 is a medication being studied as a first-line treatment for patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This medication is being tested in patients whose cancer has a mutation called KRAS G12C. The trial is looking at how well JDQ443 works in shrinking or controlling the cancer and its safety for patients. The study includes patients with different levels of a protein called PD-L1, which can affect how the cancer behaves and responds to treatment.

What is already known about the treatment

JDQ443 – JDQ443 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in treating certain types of lung cancer. It is specifically being evaluated for its effectiveness in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that have a KRAS G12C mutation. The medication works by targeting and inhibiting the KRAS G12C protein, which is involved in the growth and survival of cancer cells. JDQ443 is classified as a targeted cancer therapy, and its development is focused on providing a new treatment option for patients with this specific genetic mutation in their cancer.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to other parts of the body. In some cases, specific genetic mutations, such as KRAS G12C, can be present, influencing the cancer's behavior and progression. The expression of proteins like PD-L1 can also vary, affecting how the cancer interacts with the immune system. Co-mutations, such as those in the STK11 gene, may further impact the disease's characteristics and progression.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511708-18-00Protocol codeCJDQ443B12201Estimated enrolment120 patientsSponsorNovartis Pharma AG

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