Phase 1 Randomized Study Comparing BAT3306 and Keytruda as Adjuvant Therapy for Early Stage Non-Small Cell Lung Cancer After Surgery

What this Trial Is About

Researchers are comparing the pharmacokinetic PK similarity of BAT3306 and Keytruda in people with early stage non-small cell lung cancer NSCLC who have had their tumors completely removed by surgery. This Phase 1 study focuses on participants without EGFR gene mutations or ALK gene rearrangements, who have not received prior radiotherapy or chemotherapy, and aims to evaluate these treatments as additional adjuvant therapy after surgery. Participants will be randomly assigned to receive either BAT3306 or Keytruda through intravenous infusion at a dose of 200 mg every three weeks. This treatment will continue for up to one year, not exceeding 18 cycles. The study will collect serum samples at specific times to analyze and compare how the drugs behave in the body, their immune response effects, and safety, while also preliminarily assessing improvement in disease-free survival. During the study, participants will undergo regular evaluations including vital signs, physical exams, and laboratory tests at scheduled intervals throughout the treatment period. Researchers will monitor adverse events and collect data on disease-free survival for up to one year. The overall participation involves ongoing treatment infusions and frequent monitoring visits to assess the study outcomes and safety.

A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants