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EA5181 phase 3 trial finds no OS benefit for concurrent and consolidative durvalumab vs consolidation alone in unresectable stage 3 NSCLC

2025-09-08
(Press-News.org) (Barcelona, Spain September 8, 2025, 10:45 a.m. CEST / UTC +2)  — Treating patients who have stage III non-small cell lung cancer (NSCLC) with durvalumab concurrent with chemoradiotherapy (CRT) and continuing as consolidation therapy did not improve overall survival compared to consolidation durvalumab alone, according to research presented today at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC).

Consolidation durvalumab improves survival for patients with unresectable stage 3 NSCLC) after definitive CRT. However, the optimal timing of initiation of immune checkpoint inhibition is unknown. The Phase 3 EA5181 trial tested the hypothesis that starting durvalumab concurrently with CRT and continuing as consolidation would improve overall survival (OS) compared to consolidation durvalumab alone.

The trial enrolled 662 patients with previously untreated, unresectable stage IIIA-C NSCLC or with mediastinal node recurrence after prior surgery. Patients were randomized to receive either concurrent durvalumab with chemotherapy and radiotherapy (Arm A) or CRT alone (Arm B). Patients in both arms who completed CRT without progression or significant toxicity were assigned to one year of durvalumab consolidation.

Results showed median OS was 41.5 months in Arm A versus 39.4 months in Arm B (p=0.83, HR=1.03). Median progression-free survival (PFS) was 15.5 vs. 16.8 months (p=0.65, HR=1.05). There were no significant differences in objective response rate, patterns of failure, or toxicity between arms.

“Our study found that adding durvalumab concurrently with chemoradiotherapy did not improve overall survival compared to starting durvalumab as consolidation alone,” said John Varlotto, M.D., from Marshall University in Huntington, W.V. “These findings suggest that the current standard of initiating durvalumab after CRT remains appropriate for unresectable Stage III NSCLC.”

Dr. Varlotto pointed out that the study found ECOG performance status, adenocarcinoma histology, and DLCO > 80% were associated with significantly better outcomes, while prior thoracic surgery was linked to better PFS.

About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.

About the WCLC:
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/.

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[Press-News.org] EA5181 phase 3 trial finds no OS benefit for concurrent and consolidative durvalumab vs consolidation alone in unresectable stage 3 NSCLC