Randomized Phase 2 Study of Adebrelimab Plus Chemotherapy Before Surgery for Resectable Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Adebrelimab combined with chemotherapy as a neoadjuvant treatment for patients with resectable stage I to IIIB small cell lung cancer SCLC, with stage IIIB limited to specific tumor and lymph node involvement. This randomized, open-label, multicenter Phase 2 trial aims to compare Adebrelimab plus chemotherapy against chemotherapy alone. The primary goal is to measure pathological complete response, while secondary goals include event-free survival, major pathological response, objective response rate, disease-free survival, and safety profiles. Participants are randomly assigned to one of two groups one receives Adebrelimab together with Etoposide and a platinum-based drug Cisplatin or Carboplatin, and the other receives only Etoposide and platinum-based chemotherapy. Adebrelimab is given intravenously at a fixed dose on the first day of each 3-week cycle, followed by chemotherapy over three days. Each patient undergoes 3 to 4 treatment cycles before a 4 to 6 week break leading up to surgery for tumor removal. Treatment may be stopped early if disease worsens, side effects are intolerable, consent is withdrawn, or other specified reasons occur. During the study, patients will have assessments including scans and laboratory tests to confirm eligibility and monitor response and safety. Researchers will evaluate tumor response before surgery and pathological outcomes shortly after surgery. Participants will be followed for at least two years to assess long-term survival and disease progression. Safety monitoring continues throughout the treatment and follow-up periods to ensure participant well-being.

Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial