drugset / Trial / NCT04672928

A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies

NCT04672928

Phase 1 Completed 20 enrolled Innovent Biologics (Suzhou) Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.

Timeline

Start
2020-12-14
Primary completion
2023-01-31
Completion
2023-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI318 Unknown 300 mg Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous