Evaluating Sintilimab with Tafolecimab and Chemotherapy as First Treatment for Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the combination of Tafolecimab, Sintilimab, and chemotherapy as a first-line treatment for patients with extensive-stage small cell lung cancer ES-SCLC. This phase 2 clinical trial aims to assess the progression-free survival, safety, and biological markers related to this treatment approach. Tafolecimab is a human antibody targeting PCSK-9 to lower LDL cholesterol and increase MHC-I expression on tumor cells, while Sintilimab is an antibody targeting PD-1. Participants will receive four cycles of Tafolecimab 300 mg under the skin every 3 weeks combined with Sintilimab 200 mg intravenously every 3 weeks, plus etoposide and either carboplatin or cisplatin given intravenously on specific days of each 3-week cycle for up to 4 to 6 cycles. After these cycles, patients continue maintenance therapy with Sintilimab and Tafolecimab until the disease progresses, intolerable side effects occur, or treatment reaches two years. Continuing treatment after progression is allowed if clinical benefit is observed. During the trial, participants will undergo regular assessments to monitor their cancer response and side effects using standard criteria RECIST v1.1. Researchers will evaluate survival rates, response rates, and duration of response, as well as safety through adverse event monitoring. Biomarker studies will explore changes in tumor cells and blood samples. Participation may last up to two years or until disease progression or unacceptable toxicity, with careful ongoing evaluation throughout the study.

Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer