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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Comite Entreprise Paul Papin Angers France
Institut Gustave Roussy Villejuif France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Vitaz Sint-Niklaas Belgium
Centre De Cancerologue Du Grand Montpellier Montpellier France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Arzrqrp Uzs Tfdubvh nezc ozeyr Leghorn Italy
Hmdupozn Vqzs dxlfxgqr Barcelona Spain
Cbpang Lviq Bqngju Lyon France
Ieefnp Izfdaeno Fkhymohkstins Omnclghxgxt Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.06.2026
Denmark Denmark
Not yet recruiting
01.06.2026
France France
Not yet recruiting
01.06.2026
Italy Italy
Not yet recruiting
01.06.2026
Spain Spain
Not yet recruiting
01.06.2026

Trial locations

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.

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 ID:
2025-523537-26-00
Protocol code:
CJDQ443B12105B
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

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