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Continuation study of JDQ443 in patients with KRAS G12C‑mutated non‑small cell lung cancer receiving JDQ443 as monotherapy or drug combination

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What is this trial about?

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

The study looks at people with locally advanced or metastatic non‑small cell lung cancer that carries a specific genetic change called the KRAS G12C mutation. This mutation is a small alteration in the cancer cells that can make the disease grow faster. The medication being continued in the study is opnurasib, which is also known by the code name JDQ443. It is taken by mouth as a single pill or may be given together with other approved cancer medicines.

The main purpose of the trial is to keep participants who are still benefiting from the drug under medical supervision while safety is monitored. After joining, participants will continue to receive opnurasib on a regular schedule for as long as it remains helpful and tolerable. Visits will include simple check‑ups to record any side effects, any changes in dosage, and overall health. The study does not involve any additional invasive procedures beyond the usual care for this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment

    After joining the study, you will provide written consent and allow the study team to collect your medical history, current medications, and baseline laboratory results.

    Baseline imaging may be performed to document the extent of disease.

  2. Step 2

    Baseline assessment

    The study team will review the baseline data to confirm eligibility for continued treatment with opnurasib (jdq443).

    Any necessary safety tests, such as blood work and organ function checks, will be completed before the first dose.

  3. Step 3

    Start opnurasib (jdq443) treatment

    You will begin taking opnurasib as an oral tablet. the exact dose, frequency, and length of treatment will be determined by the investigators and written in your study medication plan.

    If you are receiving opnurasib alone, you will continue the tablet as prescribed without additional study drugs.

  4. Step 4

    Combination therapy (if applicable)

    If your physician decides that a combination is appropriate, you may also receive other study medications such as tno155 (oral capsule), erbitux (intravenous infusion), or vdt482 (intravenous infusion).

    The dose, schedule, and duration for each additional medication will be specified in your treatment plan.

  5. Step 5

    Regular monitoring visits

    You will attend scheduled clinic visits where the study team will check for side effects, perform safety laboratory tests, and assess the response of the disease.

    The frequency of these visits will follow the protocol defined by the investigators.

  6. Step 6

    Treatment continuation or discontinuation

    You will continue the assigned therapy until the study end date (30 september 2029), until you no longer benefit from the treatment, or until a safety concern requires stopping the medication.

    If treatment is stopped, you will be monitored for a defined follow‑up period as instructed by the study team.

Who can join the trial?

7 criteria

  • Give written permission after fully understanding the study (this is called informed consent).
  • Be currently taking part in a specific Novartis study and be receiving the medicine opnurasib either alone or together with another study drug.
  • Have already completed at least six treatment periods (called cycles) of opnurasib in the earlier study.
  • Be showing a positive response to the treatment, as judged by the doctor (the investigator).
  • Have followed the rules of the earlier study, as judged by the investigator (this is called compliance with the study protocol).
  • Be able and willing to attend scheduled doctor visits and follow the treatment plan.
  • Be a man or a woman, including people who might be considered vulnerable, and be within the age range allowed by the study (typically adult patients).

Who cannot join the trial?

3 criteria

  • You have been permanently discontinued from receiving the study drug opnurasib in the earlier trial for any reason other than joining this new study.
  • You are not willing to follow the required contraception (birth‑control) rules that were part of the earlier trial.
  • You currently have unresolved toxicities (side effects that have not gotten better) that caused the dosing to be interrupted (the medication was paused) in the earlier trial.
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Investigated drugs

  • TNO155

    is an oral capsule that contains batoprotafib, an experimental medicine being studied to block signals that help cancer cells grow and survive. Participants take it by mouth as part of the trial.

  • Erbitux

    is a solution for infusion that contains cetuximab, a lab‑made antibody that attaches to a protein called EGFR on the surface of some cancer cells. By binding to EGFR, it can slow the growth of those cells. It is given through an IV line.

  • JDQ443 (opnurasib)

    is an oral tablet of an investigational drug that targets a specific mutation in cancer cells, helping to stop them from multiplying. In this rollover study, participants continue to take it alone or together with other treatments.

  • VDT482

    is a concentrate for infusion that contains tislelizumab, a monoclonal antibody that helps the body’s immune system find and destroy cancer cells. It is administered through an IV infusion.

What is already known about the treatment

  • Batoprotafib

    This medication is taken by mouth in a hard‑filled capsule. It is still an experimental drug being studied in early clinical trials. It is designed to treat non‑small cell lung cancer and other solid tumors that have a KRAS G12C mutation by locking the mutant KRAS protein in an inactive state. It belongs to the class of small‑molecule KRAS inhibitors.

  • Cetuximab

    Cetuximab is given as an intravenous infusion of a clear solution. It is an approved cancer medicine that has been used for many years in colorectal and head‑and‑neck cancers. It works by attaching to the EGFR on cancer cells, stopping signals that tell the cells to grow. It is classified as a monoclonal antibody that blocks the epidermal growth factor receptor.

  • Opnurasib

    Opnurasib is taken orally as a tablet. It is currently being evaluated in clinical studies and is not yet approved for general use. The drug targets cancers with a KRAS G12C mutation, such as certain lung cancers, by binding directly to the mutant KRAS protein and keeping it turned off. It is a small‑molecule KRAS inhibitor.

  • Tislelizumab

    Tislelizumab is administered by intravenous infusion of a concentrate that is diluted before use. It is an approved therapy for several types of cancer, including some lung and bladder cancers. It works by binding to the PD‑1 receptor on immune cells, preventing the cancer from turning off the immune response. It is classified as a PD‑1 immune checkpoint inhibitor monoclonal antibody.

Investigated diseases

  • KRAS G12C‑mutated non‑small cell lung cancer

    This is a type of lung cancer that begins in the cells lining the airways and carries a specific KRAS gene change called G12C. The mutation can make cancer cells grow more quickly. In locally advanced stages, the tumor spreads to nearby structures such as lymph nodes or the chest wall. In metastatic stages, cancer cells travel through the bloodstream to distant organs like the brain, liver, or bones. As the disease progresses, the tumor usually becomes larger and may cause symptoms such as cough, shortness of breath, or chest pain.

  • KRAS G12C‑mutated solid tumor

    This term describes any solid cancer, such as those of the colon, pancreas, or other organs, that contains the KRAS G12C gene alteration. The mutation can drive uncontrolled cell growth. Over time the tumor may increase in size and invade surrounding tissues. It can also spread to other parts of the body, forming new tumor sites. The disease often moves from a localized stage to a more widespread stage as it advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523537-26-00Protocol codeCJDQ443B12105BEstimated enrolment47 patientsSponsorNovartis Pharma AG

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