Badanie fazy 3 taletrectinibu i placebo jako terapia adiuwantowa u pacjentów po całkowitym usunięciu ROS1‑dodatniego niewielokomórkowego raka płuca (stadium IB‑IIIA)

Randomization and start of medication

After you have joined the study, you will be assigned by the study team to receive either taletrectinib capsules or matching placebo capsules. The assignment is done without you knowing which one you receive.

The assigned medication is taken by mouth as one capsule containing 400 mg once each day. You will start the medication as soon as the first dose is given.

Daily medication intake

You must swallow the capsule with water each day at roughly the same time. Do not skip doses and do not change the dose unless instructed by the study staff.

Regular follow‑up visits

You will attend scheduled visits at the study site. During each visit the staff will check your health, measure vital signs, perform a physical Examination, and may record an electrocardiogram (ecg) to assess heart rhythm.

Blood samples will be taken to measure the amount of taletrectinib in your plasma and to evaluate laboratory values.

Imaging examinations may be performed to assess disease‑free survival, which means checking whether cancer has returned.

Reporting adverse events

Any new symptoms, side effects, or changes in your health must be reported to the study staff as soon as possible. These are recorded as adverse events and graded according to a standard Scale.

Study completion or discontinuation

The study continues until the planned end date of 2033‑08‑30, unless you stop the medication earlier because of side effects or at the request of the study staff.

If you stop early, you will still be asked to attend a final Assessment to document your health status.