This study is testing a new drug called EP0031 (Lunbotinib) for people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called a RET alteration. EP0031 is a type of drug called a RET-inhibitor, which targets these specific changes. The study is looking at how safe EP0031 is, what side effects it causes, and how well it works, both on its own and when given with standard chemotherapy (Cisplatin or Carboplatin, and Pemetrexed). To join, you must be at least 18 years old, have documented RET-altered NSCLC, and be in good general health. The main goal for this part of the study is to see the number of serious side effects within the first 21 days when EP0031 is combined with chemotherapy. The study has already found the best dose for EP0031 and is now in Phase 2, focusing on its safety and effectiveness with chemotherapy.

Study design

This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 2 study, and it plans to enroll 265 participants.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint measures side effects during the first 21 days of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.