Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus Durvalumab and Consolidation Immunotherapy in Patients With Resectable Stage III NSCLC.
NCT04202809 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2023-05-10
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
- DRUG
-
Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A
Sponsors & Collaborators
-
University Hospital, Essen
lead OTHER
Principal Investigators
-
Wilfried Eberhardt, PD MD · University Hospital, Essen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-13
- Primary Completion
- 2025-04-30
- Completion
- 2025-04-30
Countries
- Germany
Study Locations
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