NCT03884192

Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC

CONSIST: A Phase III Randomized Control Study of Consolidation Sintilimab (IBI308) After Concurrent Chemoradiation Versus Chemoradiation Alone in Patients With Unresectable Local Advanced Stage III NSCLC

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, randomized, control phase III trial, to compare the efficacy and safety of consolidation therapy with sintilimab (IBI308) versus best supported care (BSC), in unresectable stage III NSCLC patients who do not experience disease progression after initial concurrent chemoradiation.

Detailed description

This is an open label, multi-center, randomized, control study of sintilimab versus BSC in unresectable local advanced stage III NSCLC patients without disease progression after concurrent chemoradiation.

Conditions

• Carcinoma, Non-Small Cell Lung

Interventions

Type	Name	Description
DRUG	Consolidation Sintilimab	Sintilimab consolidation therapy after concurrent chemoradiation, 200mg IV, every 3 weeks, until progressive disease (PD, unless patients can continuously benefit from study treatment per investigators' judgement), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Sintilimab will be given at a maximum of 12 months.

Timeline

• Start date: 2018-12-12
• Primary completion: 2020-12-30
• Completion: 2021-12-30
• First posted: 2019-03-21
• Last updated: 2019-03-21

Locations

1 site across 1 country: China