Rationale and design for a multicenter, phase II study of durvalumab plus concurrent radiation therapy in locally advanced non-small cell lung cancer: The DOLPHIN Study (WJOG11619L)
Cancer Management and Research Dec 16, 2021
Tachihara M, Tsujino K, Ishihara T, et al. - This report outlines the rationale and design for a multicenter, phase II study (DOLPHIN, WJOG11619L, JapicCTI-194840) which is expected to be able to assess the efficacy and safety of durvalumab (anti-programmed cell death ligand-1) plus concurrent curative radiation therapy for PD-L1(programmed cell death ligand-1)-positive unresectable locally advanced non-small cell lung cancer (LA-NSCLC) without chemotherapy.
Enrolled participants include those with unresectable locally advanced stage III NSCLC, aged 20 years or older, with a World Health Organization/Eastern Cooperative Oncology Group performance status of 0 or 1 and PD-L1 positivity.
Patients will be administered curative radiation therapy (60 Gy) plus durvalumab 10 mg/kg every 2 weeks (q2w) for up to 12 months until evidence of disease progression or unacceptable toxicity.
Twelve-month progression-free survival rate, as assessed by an independent central review, is defined as the primary endpoint.
Secondary endpoints include progression-free survival, overall survival, objective response rate, treatment completion rate, and safety.
Recruitment commenced in September 2019.
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