drugset / Trial / NCT04840290

A Neoadjuvant Study of Sintilimab Plus Platinum Doublet Chemotherapy in IIIA(N2) Stage NSCLC

NCT04840290

Phase 3 Unknown 30 enrolled Tang-Du Hospital
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the feasibility and evaluate the safety of delivering chemotherapy, the usual approach to non-small cell lung cancer, in combination with Sintilimab (PD-1 antibody), followed by adjuvant therapy after surgical resection. Consolidation therapy is treatment given following the initial treatment. Sintilimab is an investigational drug, which has been approved by the NMPA(National Medical Products Administration,China. https://www.nmpa.gov.cn/) for use in late stage of non-small cell lung cancer (NSCLC). Sintilimab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.

Timeline

Start
2019-06-01
Primary completion
2023-06-01
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Cisplatin Other / unclassified
Subject Paclitaxel Small molecule
Subject Sintilimab Monoclonal antibody