Durvalumab With Radiation Therapy in Patients With Inoperable Locally Advanced Non-Small Cell Lung Cancer Ineligible for Concurrent Chemoradiotherapy (DART).

Authors

Andreas Rimner, Emily S Lebow, Kelly J Fitzgerald, Leah Kratochvil, Nicolas Toumbacaris, Daphna Y Gelblum, Rupesh Kotecha, Daniel R Gomez, Abraham J Wu, Annemarie F Shepherd, Ellen D Yorke, Juliana Eng, Kenneth Ng, Gregory J Riely, Afsheen Iqbal, Charles M Rudin, David R Jones, James M Isbell, Gaetano Rocco, Valerie W Rusch, Michelle S Ginsberg, Zhigang Zhang, Charles B Simone, Mark G Kris, Narek Shaverdian, Jamie E Chaft

Published in

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. Pages JCO2502517. Jul 16, 2026. Epub Jul 16, 2026.

Abstract

Concurrent platinum-based chemotherapy and radiation therapy (cCRT) followed by consolidative durvalumab is the standard of care (SoC) for fit patients with inoperable, locally advanced non-small cell lung cancer (LA-NSCLC). However, no SoC exists for patients who are cCRT-ineligible because of age, comorbidities, or frailty. Here, we investigated the efficacy and adverse events (AEs) of concurrent and consolidative durvalumab with definitive radiation therapy (RT) without chemotherapy.
In this multicenter, single-arm, prospective phase II study, patients received conventionally fractionated RT plus concurrent and consolidative durvalumab (1,500 mg fixed dose once every 4 weeks) for up to 12 months. The primary end point was 2-year progression-free survival (PFS) of 36% compared with historical results of 20% with sequential CRT (86% power). Additional end points included overall survival (OS) and cancer-specific survival (CSS).
Fifty-eight patients (median age 82 years [IQR, 76-86]; 16 [28%] PD-L1-negative; eight [14%] Eastern Cooperative Oncology Group [ECOG] score 2; 46 [79%] ECOG score 1; four [7%] ECOG score 0) were treated per protocol. The study met its primary end point with a 2-year PFS of 39% (one-sided CI, 29 to 100) and a 2-year OS of 54%. Better performance status and PD-L1 positivity were associated with improved PFS; better ECOG was associated with improved OS; PD-L1 positivity was associated with better CSS. Grade 3/4 treatment-related AEs occurred in 12 (21%) patients. Grade 5 AEs occurred in four (7%) patients (radiation pneumonitis (n = 2) and cardiac arrest (n = 2)). Durvalumab was discontinued early because of AEs in 18 (31%) patients.
Thoracic RT with concurrent and consolidative durvalumab is a promising treatment option for cCRT-ineligible patients with LA-NSCLC, demonstrating better PFS with a favorable safety profile compared with historical controls.

PMID:
42462186
Bibliographic data and abstract were imported from PubMed on 17 Jul 2026.

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