Phase II Study of Pembrolizumab and Plinabulin Combined with Etoposide and Platinum for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are studying a new combination treatment for patients with extensive-stage small-cell lung cancer ES-SCLC. This phase II study focuses on evaluating the safety and effectiveness of Pembrolizumab, Plinabulin, Etoposide, and Platinum as a first-line therapy. Pembrolizumab, a drug that targets PD-1, has shown promising results when combined with chemotherapy. Plinabulin, recently approved for preventing chemotherapy-induced neutropenia, is being tested alongside Pembrolizumab and chemotherapy to improve treatment response and reduce side effects in this patient group. Participants will receive Pembrolizumab 200 mg intravenously every three weeks, along with Etoposide on days 1, 2, and 3, and either Carboplatin or Cisplatin on day 1 every three weeks. Plinabulin will also be given intravenously on day 1 every three weeks. This single-arm trial involves receiving this combination as the first treatment for ES-SCLC, with treatment cycles continuing as planned according to the study protocol. During the study, participants will undergo regular assessments to monitor disease progression, treatment response, and safety. The main outcome measured is the progression-free survival rate at 12 months, with additional evaluations including overall response rate, duration of response, overall survival, and treatment-related side effects over up to 24 months. Participants will be closely observed for adverse events and treatment effects throughout the study period.

First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC