Phase II Study of Pumitamig Combined With Chemotherapy for Advanced or Metastatic Non-small Cell Lung Cancer After First-line Treatment

What this Trial Is About

Researchers are evaluating the combination of pumitamig also known as BNT327 or PM8002 with standard chemotherapy docetaxel in people with advanced or metastatic Non-small Cell Lung Cancer NSCLC that has progressed after first-line chemoimmunotherapy. This Phase II, multisite, open-label study aims to assess the safety and preliminary effectiveness of this combination treatment in this patient group. The study is designed in two parts to carefully monitor safety and expand dosing if appropriate. In Part 1, up to 12 participants will receive one of two dose levels of pumitamig combined with docetaxel in a safety run-in phase. Based on safety assessments, an internal review committee will decide whether to proceed to Part 2, where up to 54 additional participants will receive the recommended dose combination. In Part 2, some participants will also provide fresh tumor biopsy samples at baseline and during treatment for further analysis. Treatment continues until disease progression, unacceptable side effects, withdrawal, death, study end, or a 2-year limit. Participants will undergo regular assessments including safety monitoring for adverse events, dose adjustments, and tumor response using standard criteria. After treatment ends, a long-term follow-up will collect information on disease progression, new cancer treatments, and survival status. The primary outcomes focus on safety and response rates, while secondary outcomes include duration of response, progression-free survival, overall survival, and pharmacokinetics of pumitamig over approximately two years.

Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment