NCT04202809

Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus Durvalumab and Consolidation Immunotherapy in Patients With Resectable Stage III NSCLC.

Prospective Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus the PD-L1 Antibody Durvalumab Followed by Surgery or Definitive Chemoradiation Boost and Consolidation Durvalumab in Resectable Stage III NSCLC.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

To compare a complex induction multimodality protocol (ESPATUE) + concurrent immunotherapy with PD-L1 antibody Durvalumab given every three weeks to the same induction multimodality protocol without Durvalumab immunotherapy induction followed by definitive local treatment (surgery for those considered resectable or chemoradiation boost for those not considered to be R0-resectable) followed by consolidation Durvalumab treatment in both arms.

Conditions

• NSCLC, Stage III

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A

Timeline

• Start date: 2020-01-13
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2019-12-18
• Last updated: 2023-05-10

Locations

7 sites across 1 country: Germany