Phase II Study Evaluating Bemotuzumab Combined with Chemotherapy and Anlotinib Followed by Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with untreated extensive-stage small cell lung cancer ES-SCLC in this Phase II clinical trial. The study aims to assess the effectiveness and safety of a combined therapy that includes the drug Bemotuzumab, chemotherapy, and Anlotinib, followed by thoracic radiotherapy. Approximately 25 patients will participate to help determine how well this treatment delays cancer progression and its safety profile. Participants will undergo a multi-phase treatment plan. The induction phase involves four cycles of Bemotuzumab given intravenously along with standard platinum-etoposide chemotherapy and oral Anlotinib taken daily for two weeks followed by a week off. Patients who show disease control will move to the consolidation phase, receiving Bemotuzumab, Anlotinib, and targeted thoracic radiotherapy administered over five sessions. Finally, a maintenance phase continues with Bemotuzumab and Anlotinib until disease progression or unacceptable side effects occur, with dose adjustments allowed for Anlotinib as needed. During the study, participants will have regular assessments including scans to measure tumor response, laboratory tests to check blood counts and organ function, and monitoring for side effects. The main outcome measured is progression-free survival, tracked for up to 24 months. Additional outcomes include response rates, overall survival, and immune-related adverse events. Participants will be followed closely throughout the treatment and observation periods to monitor their health and treatment effects.

A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer