Study of IN10018 With Tislelizumab, Carboplatin, and Etoposide as First Treatment for Extensive-stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the combination of IN10018 with an anti-PD-1L1 antibody Tislelizumab and chemotherapy carboplatin and etoposide as a first treatment in people with extensive-stage small cell lung cancer ES-SCLC. This open-label, randomized phase IbII study aims to assess the anti-tumor effects, safety, tolerability, and how the body processes IN10018 in this patient group. The study is sponsored by InxMed Shanghai Co., Ltd and aims to find the best dose and compare treatment effects over up to three years. The trial is divided into two parts the first part to confirm the dose and safety of IN10018 combined with Tislelizumab, carboplatin, and etoposide the second part to compare the experimental combination to the control group receiving Tislelizumab with carboplatin and etoposide. IN10018 is taken orally once daily, while Tislelizumab, carboplatin, and etoposide are given intravenously on a three-week cycle with specified doses and schedules. Participants will undergo assessments including tumor measurements, safety evaluations, and pharmacokinetic studies to monitor how the drug behaves in the body. Researchers will follow progression-free survival, response rates, duration of response, disease control, overall survival, and adverse events for up to three years. Eligibility includes adults aged 18 to 75 with confirmed ES-SCLC who have not received prior systemic therapy. The study involves regular visits for treatment administration, monitoring, and data collection throughout the treatment and follow-up periods.

IN10018 Combination Therapy in Treatment-naïve ES-SCLC