Phase II Study of Adebrelimab, Apatinib Mesylate, and Chemotherapy Followed by Surgery and Radiotherapy in Limited-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for adults with newly diagnosed limited-stage small cell lung cancer that can be surgically removed stage T1-3N0-1M0. This phase II clinical study explores the use of adebrelimab combined with chemotherapy and apatinib mesylate before surgery, followed by additional therapy after surgery based on individual patient assessments. The study also recommends specific radiotherapy for certain patients depending on disease stage before and after surgery. Participants receive four cycles of adebrelimab at 1200 mg every three weeks along with chemotherapy including etoposide and carboplatin every three weeks for four cycles. Concurrently, apatinib mesylate is given orally three times a week for three cycles. Surgery is scheduled within four to eight weeks after completing these treatments, with apatinib stopped four weeks prior to surgery. After surgery, treatment with adebrelimab and apatinib, with or without radiotherapy, starts four weeks later, guided by a multidisciplinary teams recommendations. During the study, participants undergo regular evaluations including tumor assessments according to RECIST 1.1 criteria. Researchers track event-free survival over two years as the primary outcome, along with other measures such as major pathological response, overall survival, objective response rate, treatment side effects, and pathological complete response. Safety, tolerability, and treatment effects are monitored throughout up to two years, with detailed follow-up to assess the impact of the combined therapies.

A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer