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

Sponsor
University Hospital, Essen
Study ID
NCT04202809
Phase
PHASE2
Status
Unknown

Conditions

  • NSCLC, Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A

Study Details

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.

Key Dates

Start date
Jan 13, 2020
Status verified
May 2023
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemo- and Radiochemotherapy + Durvalumab
  • No Intervention: Chemo- and Radiochemotherapy

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 2 years ]

Central Contacts

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