Phase III Study of AL8326 Tablets Versus Placebo for Patients With Advanced or Recurrent Small Cell Lung Cancer After Two or More Prior Treatments

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AL8326 tablets in patients with small cell lung cancer SCLC who have experienced disease progression or recurrence after receiving at least two prior treatment regimens. This phase III, multicenter, randomized, double-blind, placebo-controlled study aims to compare AL8326 tablets with a placebo in this patient population. The study involves patients with confirmed SCLC who need third-line or later therapy and have measurable tumor lesions. Participants are randomly assigned in a 21 ratio to receive either AL8326 tablets or a placebo. Both treatments are given orally once daily in 28-day cycles, continuing until intolerable side effects, disease progression, death, voluntary withdrawal, or up to 12 months about 13 cycles. After treatment ends, participants have a final visit and then enter a long-term follow-up period where tumor status is monitored based on RECIST 1.1 criteria. Throughout the study, participants undergo regular assessments including overall survival tracked up to three years, progression-free survival, tumor response rates, duration of remission, disease control, and monitoring for adverse events. Blood samples are collected at specified cycles to measure plasma drug concentration. The study also includes safety monitoring and requires participants to meet specific health criteria before and during treatment.

A Phase IIII Study of AL8326 in Small Cell Lung Cancer