NCT05177497

SHR-1701 for Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III NSCLC

A Phase II Trial of SHR-1701 Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III Non-small-cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, single arm study, aiming to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III non-small-cell lung cancer (NSCLC)

Detailed description

The PACIFIC trial showed that durvalumab consolidation therapy significantly improved PFS and OS versus placebo for patients with unresectable stage III NSCLC after chemoradiotherapy. Pacific regimen has become the standard of care for patients with unresectable stage III NSCLC. SHR-1701, a novel bifunctional fusion protein composed of a mAb against PD-L1 fused with the extracellular domain of TGF-β receptor II, has demonstrated anti-tumor activity in early clinical trials. In this study, the investigators aim to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III NSCLC.

Conditions

• NSCLC, Stage III

Interventions

Type	Name	Description
DRUG	SHR-1701	SHR-1701 administered by iv

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2022-01-04
• Last updated: 2022-01-04