A Phase 3 Study of Taletrectinib versus Placebo in People with Non-Small Cell Lung Cancer After Complete Tumor Removal

In the U.S.

Full Title

A Phase 3 Multicenter Double-Blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection (Advarra)

Purpose

Researchers are comparing taletrectinib with a placebo (inactive drug) in people with non-small cell lung cancer (NSCLC). The people in this study have stage 1B-3A NSCLC that has a ROS1 gene fusion. They have had the tumor completely removed with surgery.

If you take part in this study, you will be randomly assigned to get taletrectinib or a placebo. You will take the treatment for up to 3 years, or unless your cancer gets worse. Both taletrectinib and the placebo are capsules taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

Have ROS1 fusion-positive stage 1B-3A NSCLC that has been surgically removed.
Have completed surgery at least 4 weeks but no more than 16 weeks before taking the study therapy.
Have completed post-surgery chemotherapy at least 7 days before the study treatment, if you had chemotherapy.
Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
Be age 18 or older.