Open‑label rollover study of JDQ443 (opnurasib) as monotherapy or drug combination in patients with KRAS G12C‑mutated advanced non‑small cell lung cancer

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What is this study about?

The study focuses on people with KRAS G12C‑mutated non‑small cell lung cancer, a common type of lung cancer that has a specific change in the KRAS gene, and on patients with advanced solid tumors that also carry this KRAS change. The KRAS G12C mutation is a tiny alteration in the DNA that can make cancer cells grow faster. Participants are receiving the investigational medicine opnurasib (JDQ443), which may be given alone or together with other cancer drugs such as batoprotafib, cetuximab, or tislelizumab. “Locally advanced” means the cancer has grown beyond its original spot but has not yet spread to distant parts of the body, while “metastatic” indicates it has spread to other organs.

The purpose of the study is to provide continued access to opnurasib for participants who are still benefiting from it. After enrollment, participants will keep taking the medication on a regular schedule and will attend periodic clinic visits where doctors check how they feel, record any side effects, and may adjust the dose if needed. The study follows each person for as long as the treatment continues to be helpful, while closely monitoring safety and tolerability.

1 baseline assessment

you attend a study visit after joining. during this visit, health information, blood tests, and imaging are performed to document the current condition of the cancer.

the results are used to confirm eligibility for continuing treatment with opnurasib.

2 start opnurasib (jdq443) oral tablet

you receive jdq443, marketed as opnurasib, in tablet form to be taken by mouth.

the tablet is taken according to the study schedule, typically once daily, and continued for as long as clinical benefit is observed or until the study end date of 2029-09-30.

3 optional batoprotafib (tno155) oral capsule

if your treatment plan includes combination therapy, you are given tno155, which contains the substance batoprotafib, in a hard capsule.

the capsule is taken by mouth as directed by the study protocol, usually once daily, alongside the opnurasib tablet.

4 cetuximab (erbitux) intravenous infusion

when combination therapy requires cetuximab, you receive the medication as an intravenous infusion (a drip given through a vein).

the infusion is administered in a clinic setting, typically lasting about one hour, and is repeated on the schedule defined by the study (for example, every two weeks).

5 tislelizumab (vdt482) intravenous infusion

if your regimen includes tislelizumab, you receive it as a concentrated solution for intravenous infusion.

the infusion is performed in the clinic, usually over a short period, and is repeated according to the study schedule (for example, every three weeks).

6 regular follow‑up visits

you attend scheduled study visits to evaluate safety and effectiveness. during each visit, blood tests, physical examinations, and imaging may be performed.

any side effects are recorded, and dose adjustments or temporary interruptions are made if necessary.

7 continuation or discontinuation of treatment

treatment continues until disease progression, unacceptable side effects, or the official study end date of 2029-09-30.

if treatment is stopped, you will have a final assessment to document the outcome.

Who Can Join the Study?

You must sign a document called informed consent that shows you understand the study and agree to take part.
You must already be enrolled in a specific Novartis study and be receiving the medicine opnurasib, either by itself or together with other treatments.
You must have completed at least six treatment cycles (a cycle is a set period of taking the medicine) of opnurasib in that earlier study.
You must still be getting a positive effect from the treatment, which the study doctor (the investigator) will confirm as clinical benefit.
You must have followed the rules of the earlier study as judged by the investigator, showing good compliance.
You must be willing and able to attend all scheduled visits and follow the treatment plan.
The study includes both men and women, may include people who need extra protection (vulnerable participants), and you must be within the age range defined by the trial.

Who Cannot Join the Study?

You cannot join if you have already been permanently stopped from taking opnurasib in the earlier study, unless the only reason you stopped was to enroll in this new study.
You must agree to follow the birth‑control (contraception) rules that were required in the earlier study; if you are not willing to do that, you cannot take part.
You cannot join if you currently have side effects (called toxicities) that have not gotten better and that caused the dose of opnurasib to be paused in the earlier study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
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
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
Arunszy Uir Thliypz noya ojjwc	Leghorn	Italy
Hshrgdia Vvxt dbgkyfdn	Barcelona	Spain
Cwgeop Lfcp Bbxulo	Lyon	France
Irxenb Iogkstqd Fvwotiymcwcyl Oyvcmlbeuxo	Rome	Italy

Trial status

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

Trial locations

Investigated drugs:

TNO155 is an experimental oral capsule taken by mouth. It contains a drug called batoprotafib that is designed to block a specific protein inside cancer cells, which may help slow the growth of the tumor. In this study it is being tested either by itself or together with other treatments.

Erbitux is a medicine given through an IV infusion. It contains cetuximab, an antibody that attaches to a protein on the surface of certain cancer cells. By binding to this protein, it helps stop the cells from multiplying and can also help the immune system recognize the cancer.

opnurasib (JDQ443) is an oral tablet taken by mouth. It works by inhibiting a signaling pathway that many tumors use to grow and spread. Participants in this rollover study continue to receive opnurasib because it has been providing them with clinical benefit.

tislelizumab (VDT482) is administered by IV infusion. It is an antibody that blocks the PD‑1 protein on immune cells, which allows the body’s immune system to better detect and attack cancer cells. It may be used alone or in combination with other study drugs.

KRAS G12C‑mutated non‑small cell lung cancer, locally advanced or metastatic – This is a type of lung cancer that starts in the larger airway cells and carries a specific KRAS G12C genetic change. When locally advanced, the tumor has grown beyond its original site but remains near the lung. In the metastatic stage, cancer cells have spread to distant parts of the body such as other lungs, bones, or the brain. The disease progresses as tumor cells continue to divide and invade surrounding tissues. Over time, the number of affected sites can increase as the cancer spreads.

KRAS G12C‑mutated advanced solid tumors – These are cancers that arise in solid organs and contain the KRAS G12C mutation. They are considered advanced when they have grown large or spread beyond the organ where they began. The mutation promotes rapid cell growth and invasion into nearby tissues. As the disease advances, cancer cells may travel through the bloodstream to form new growths in other body regions. The condition continues to evolve as more cells acquire the same genetic alteration.

Trial ID:

2025-523537-26-00

Protocol code:

CJDQ443B12105B

Trial Phase:

Human Pharmacology (Phase I) – Other

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Open‑label rollover study of JDQ443 (opnurasib) as monotherapy or drug combination in patients with KRAS G12C‑mutated advanced non‑small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?