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      Durvalumab Plus Concurrent Radiotherapy for Treatment of Locally Advanced Non–Small Cell Lung Cancer : The DOLPHIN Phase 2 Nonrandomized Controlled Trial

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          Administration of durvalumab after concurrent chemoradiotherapy is the standard treatment of unresectable, locally advanced non–small cell lung cancer (NSCLC); however, 20% to 30% of patients do not receive durvalumab because of adverse events (AEs) during concurrent chemoradiotherapy. In addition, radiotherapy and immunotherapy have a synergistic effect.


          To investigate the efficacy and safety of durvalumab immunotherapy plus concurrent radiotherapy followed by maintenance with durvalumab therapy for treatment of locally advanced NSCLC without chemotherapy.

          Design, Setting, and Participants

          The multicenter, single-arm DOLPHIN (Phase II Study of Durvalumab [MEDI4736] Plus Concurrent Radiation Therapy in Advanced Localized NSCLC Patients) nonrandomized controlled trial was performed by 12 institutions in Japan from September 13, 2019, to May 31, 2022. Participants in the primary registration phase included 74 patients with programmed cell death ligand 1 (PD-L1)-positive, unresectable, locally advanced NSCLC. The current analyses were conducted from June 1, 2022, to October 31, 2022.


          Patients received radiotherapy (60 Gy) in combination with concurrent and maintenance durvalumab immunotherapy, 10 mg/kg every 2 weeks, for up to 1 year.

          Main Outcomes and Measures

          The primary end point of the rate of 12-month progression-free survival (PFS), as assessed by an independent central review, was estimated using the Kaplan-Meier method and evaluated with 90% CIs calculated using the Greenwood formula. The key secondary end points were PFS, objective response rate, treatment completion rate, and AEs.


          Data from 35 patients (median [range] age, 72 [44–83] years; 31 [88.6%] men) were included in the full analysis set of the evaluable population. The 12-month PFS rate was 72.1% (90% CI, 59.1%-85.1%), and the median PFS was 25.6 months (95% CI, 13.1 months to not estimable) at a median follow-up of 22.8 months (range, 4.3-31.8 months). Scheduled radiation therapy was completed in 97.1% of patients. The confirmed objective response rate was 90.9% (95% CI, 75.7%-98.1%), and the treatment completion rate was 57.6% (95% CI, 39.2%-74.5%). Among 34 patients evaluated in the safety analysis set, AEs of grade 3 or 4 occurred in 18 patients (52.9%), and of grade 5 in 2 patients (5.9%). Pneumonitis or radiation pneumonitis of any grade occurred in 23 patients (67.6%), and of grades 3 or 4 in 4 patients (11.8%).

          Conclusions and Relevance

          Findings from this phase 2 nonrandomized controlled trial indicate that durvalumab immunotherapy combined with curative radiotherapy for patients with PD-L1–positive, unresectable, locally advanced NSCLC is a promising treatment with tolerable AEs and is appropriate as a study treatment for phase 3 clinical trials.

          Trial Registration

          Japan Registry of Clinical Trials ID: jRCT2080224763

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          Most cited references23

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

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            Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

            Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).
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              Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial

              First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival after treatment with pembrolizumab monotherapy in patients with a PD-L1 TPS of 1% or greater.

                Author and article information

                JAMA Oncology
                JAMA Oncol
                American Medical Association (AMA)
                September 07 2023
                [1 ]Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
                [2 ]Department of Radiation Oncology, Hyogo Cancer Center, Akashi, Japan
                [3 ]Division of Radiation Oncology, Kobe University Graduate School of Medicine, Kobe, Japan
                [4 ]Department of Medical Oncology, Kindai University, Osakasayama, Japan
                [5 ]Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
                [6 ]Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan
                [7 ]Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan
                [8 ]Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
                [9 ]Internal Medicine III, Wakayama Medical University, Wakayama, Japan
                [10 ]Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan
                [11 ]Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan
                [12 ]Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
                [13 ]Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
                [14 ]Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan
                [15 ]Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan
                © 2023


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