Patient-Reported Outcomes with Consolidation Durvalumab Versus Placebo Following Concurrent Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer: Results from the Phase 3 ADRIATIC Trial

Silvia Novello; Ying Cheng; David Spigel; Jian Fang; Yuanbin Chen; Yoshikata Zenke; Ki Hyeong Lee; Alejandro Navarro; Eva Buchmeier; John Wen-Cheng Chang; Yoshimasa Shiraishi; Mustafa Özgüroğlu; Yu Jung Kim; Nguyen Thi Thai Hoa; Sayed M S Hashemi; Anne C Chiang; Ralph Turner; Helen Mann; Yuka Olivo; Haiyi Jiang; Suresh Senan

doi:10.1016/j.jtho.2026.103564

Patient-Reported Outcomes with Consolidation Durvalumab Versus Placebo Following Concurrent Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer: Results from the Phase 3 ADRIATIC Trial

J Thorac Oncol. 2026 Jan 30:103564. doi: 10.1016/j.jtho.2026.103564. Online ahead of print.

Authors

Silvia Novello¹, Ying Cheng², David Spigel³, Jian Fang⁴, Yuanbin Chen⁵, Yoshikata Zenke⁶, Ki Hyeong Lee⁷, Alejandro Navarro⁸, Eva Buchmeier⁹, John Wen-Cheng Chang¹⁰, Yoshimasa Shiraishi¹¹, Mustafa Özgüroğlu¹², Yu Jung Kim¹³, Nguyen Thi Thai Hoa¹⁴, Sayed M S Hashemi¹⁵, Anne C Chiang¹⁶, Ralph Turner¹⁷, Helen Mann¹⁸, Yuka Olivo¹⁹, Haiyi Jiang²⁰, Suresh Senan¹⁵

Affiliations

¹ Department of Oncology, University of Turin, AOU San Luigi Gonzaga, Orbassano, Italy. Electronic address: silvia.novello@unito.it.
² Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China.
³ Sarah Cannon Research Institute, Nashville, TN, United States.
⁴ Department of Thoracic Medical Oncology, Peking University Cancer Hospital, Beijing Cancer Hospital, Beijing, China.
⁵ Cancer & Hematology Centers of Western Michigan, Holland, MI, United States.
⁶ Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
⁷ Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea.
⁸ Medical Oncology Department, Hospital Vall d'Hebron and Vall d'Hebron Institute of Oncology, Barcelona, Spain(∗).
⁹ Department of Thoracic Oncology, Hospitals of the City of Cologne gGmbH, Cologne, Germany.
¹⁰ Chang Gung Medical Foundation-LinKou Branch, New Taoyuan City, Taiwan.
¹¹ Department of Respiratory Medicine, Kyushu University Hospital, Fukuoka, Japan.
¹² Department of Internal Medicine, Division of Medical Oncology, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Türkiye.
¹³ Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
¹⁴ National Cancer Hospital, Hanoi, Vietnam.
¹⁵ Department of Pulmonary Medicine, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.
¹⁶ Department of Medicine (Medical Oncology), Yale University School of Medicine, New Haven, CT, United States.
¹⁷ Patient Centered Solutions, IQVIA, Durham, NC, United States.
¹⁸ Biostatistics, AstraZeneca, Macclesfield, United Kingdom.
¹⁹ Oncology R&D, AstraZeneca, New York, NY, United States.
²⁰ Oncology R&D, AstraZeneca, Gaithersburg, MD, United States.

PMID: 41621752
DOI: 10.1016/j.jtho.2026.103564

Abstract

Introduction: In the first interim analysis of the phase 3 ADRIATIC trial, consolidation durvalumab significantly improved overall survival and progression-free survival (primary endpoints) versus placebo in patients with limited-stage small-cell lung cancer (LS-SCLC) without disease progression after concurrent chemoradiotherapy (cCRT). We report the patient-reported outcomes.

Methods: Patients received durvalumab, durvalumab-tremelimumab, or placebo every 4 weeks for up to 24 months. Patient-reported global health status/quality of life (GHS/QoL), functioning, and symptoms, assessed using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30/Questionnaire-Lung Cancer 13 (secondary endpoints), are reported for durvalumab and placebo only; the durvalumab-tremelimumab arm remained blinded at this analysis. Change from baseline (for prespecified key scales), time to deterioration (TTD), and improvement rates (all scales) were examined. A score change of ≥10 from baseline was considered a clinically meaningful deterioration/improvement. Analyses were not alpha-controlled.

Results: In both arms (durvalumab, n=264; placebo, n=266), mean score changes in prespecified key scales from baseline up to 24 months were small and not clinically meaningful. There were no between-arm differences in TTD except for arm/shoulder pain (longer with durvalumab versus placebo [median TTD: 25.7 versus 9.1 months; HR: 0.70 (95% CI: 0.51-0.94)]) and similar improvement rates between arms for most scales; a higher improvement rate for chest pain was observed with durvalumab versus placebo (odds ratio: 2.28 [95% CI: 1.08-4.95]).

Conclusions: Consolidation durvalumab following cCRT did not compromise patients' GHS/QoL, functioning, or symptoms versus placebo, further supporting this treatment regimen as the new standard of care for LS-SCLC.

Keywords: ADRIATIC; consolidation; durvalumab; limited-stage small-cell lung cancer; patient-reported outcomes.