drugset / Trial / NCT05088967

Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer

NCT05088967

Phase 1 Terminated 6 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the neoadjuvant therapy efficacy of IBI110 in combination with sintilimab versus sintilimab alone based on pathologic complete response (pCR) rate in stage IIB (primary tumor \> 4 cm ) to IIIB (N2 only) subjects with radically resectable NSCLC.

Timeline

Start
2021-12-02
Primary completion
2021-12-31
Completion
2023-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject NEGALSTOBART Monoclonal antibody Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous