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

A 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	paclitaxel	80mg/m\^2,iv,Q4W
DRUG	IBI318	300mg,iv,Q4W

Timeline

• Start date: 2020-12-14
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2020-12-17
• Last updated: 2023-02-27

Locations

1 site across 1 country: China