Phase III Study Comparing Pumitamig Plus Chemotherapy Versus Atezolizumab Plus Chemotherapy for First-line Treatment of Extensive-stage Small-cell Lung Cancer

What this Trial Is About

Researchers are conducting a Phase III, multisite, randomized, double-blinded trial to compare pumitamig BNT327 combined with chemotherapy etoposide and carboplatin against atezolizumab combined with the same chemotherapy in participants with previously untreated extensive-stage small-cell lung cancer ES-SCLC. The study aims to evaluate treatment safety and effectiveness, including overall survival and progression-free survival. The study includes two stages Stage 1 has two treatment arms with different doses of pumitamig and one control arm receiving atezolizumab, while Stage 2 has one treatment arm with a different pumitamig dose and a control arm. Treatment involves intravenous infusions of the study drugs and chemotherapy. Participants may switch from carboplatin to cisplatin if carboplatin is not tolerated. Each stage consists of a screening period, an induction and maintenance treatment period lasting up to 2 years or until disease progression or other endpoints, followed by a safety and survival follow-up phase. Participants undergo screening for eligibility before randomization. During the study, researchers monitor overall survival up to approximately 46 months, progression-free survival, response rates, adverse events, and quality of life through questionnaires. Safety follow-up visits occur after treatment ends. The total participation time may extend over several years, including treatment and follow-up assessments to evaluate long-term outcomes and safety.

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer