Phase 2 Study of Alisertib Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Received Prior Chemotherapy and Immunotherapy

What this Trial Is About

Researchers are evaluating alisertib as a single treatment in patients with small cell lung cancer SCLC that has progressed after prior therapies. This Phase 2 study focuses on patients who have already received at least one platinum-based chemotherapy and an anti-PD-L1PD-1 immunotherapy, with allowance for up to two prior treatment regimens in total. The study aims to identify specific biomarker groups that may respond best to alisertib and to assess its effectiveness, safety, and how the body processes the drug. Participants will receive alisertib tablets orally in doses of 50 mg, 60 mg, or 70 mg twice daily for seven days within each 21-day treatment cycle. The dosing amount depends on protocol amendments and is given on a schedule of days 1 to 7 of each cycle. This treatment continues under close monitoring to evaluate patient response and side effects. During the study, participants will be regularly evaluated for response to treatment, including measures such as tumor shrinkage and disease control, lasting up to 36 months after the first dose. Researchers will also assess progression-free survival and overall survival within biomarker-defined groups and the overall enrolled population. Safety is monitored by tracking adverse events from the start of treatment through 28 days after the last dose. Patients will be followed for up to three years to gather comprehensive data on treatment outcomes and safety.

A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer