A Phase 3 Study Comparing Tarlatamab to Investigator-Selected Chemotherapy in Adults With Advanced Poorly Differentiated Pulmonary or Gastroenteropancreatic Neuroendocrine Carcinomas

What this Trial Is About

Researchers are evaluating the effectiveness of tarlatamab compared to standard chemotherapy treatments in patients with advanced, poorly differentiated neuroendocrine carcinomas NECs of the lung or gastroenteropancreatic system who have already received prior treatment. This phase 3 trial aims to explore how well tarlatamab works in this patient group, following evidence of its efficacy in small-cell lung cancer. The study is sponsored by the Intergroupe Francophone de Cancerologie Thoracique and focuses on patients with specific tumor characteristics, including DLL3 expression and tumor progression after platinum-based therapy. Participants will be randomly assigned to one of two groups one group will receive tarlatamab at a dose of 10 mg every two weeks, and the other will receive standard chemotherapy chosen by the investigator. Standard chemotherapy options may include immune checkpoint inhibitors, docetaxel, topotecan for lung tumors, or FOLFOX, FOLFIRI, or alkylating-based chemotherapy for digestive tumors. Treatments will be administered according to the schedule determined by the study protocol. During the study, participants will be monitored through various assessments including tumor response evaluations, safety and tolerability checks, and quality of life questionnaires using the EORTC QLQ-C30. The primary outcome is overall survival measured over about four years. Secondary outcomes include objective response rate, duration of response, disease control rate, and progression-free survival. Patients will be followed closely to assess treatment effects and side effects throughout the trial period, which begins after screening and informed consent.

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)