Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer
| Autor: | Suresh Senan, Norah J. Shire, H. Jiang, Yuanbin Chen, Wenliang Yao, Gabriel Mak, Gyeong Won Lee, Byoung Chul Cho, Isamu Okamoto, Seiji Niho |
|---|---|
| Přispěvatelé: | Radiation Oncology |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine Oncology Adult Male Cancer Research medicine.medical_specialty Durvalumab Lung Neoplasms Adolescent medicine.medical_treatment Placebo-controlled study Placebo Antibodies Monoclonal Humanized 03 medical and health sciences Young Adult 0302 clinical medicine Double-Blind Method Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Lung cancer Aged Aged 80 and over Chemotherapy business.industry Antibodies Monoclonal Chemoradiotherapy Middle Aged medicine.disease Prognosis Small Cell Lung Carcinoma Radiation therapy 030104 developmental biology Tolerability Research Design 030220 oncology & carcinogenesis Female business Tremelimumab medicine.drug Follow-Up Studies |
| Zdroj: | Clinical Lung Cancer, 21(2), e84-e88. Elsevier Senan, S, Okamoto, I, Lee, G-W, Chen, Y, Niho, S, Mak, G, Yao, W, Shire, N, Jiang, H & Cho, B C 2020, ' Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer : The ADRIATIC Study ', Clinical Lung Cancer, vol. 21, no. 2, pp. e84-e88 . https://doi.org/10.1016/j.cllc.2019.12.006 |
| ISSN: | 1525-7304 |
| Popis: | Limited-stage (LS) small-cell lung cancer (SCLC) remains an area of high unmet medical need. The standard-of-care therapy comprises curative-intent platinum-based chemotherapy with concurrent radiotherapy (cCRT), which can be followed by prophylactic brain irradiation and then observation. However, most patients will relapse. Durvalumab (antiprogrammed cell death ligand-1) has enhanced the efficacy outcomes after cCRT for patients with unresectable, stage III non-small-cell lung cancer. Recently, durvalumab combined with platinum-etoposide demonstrated a significant survival benefit compared with platinum-etoposide as first-line treatment of patients with extensive-stage SCLC and has also shown antitumor activity as monotherapy and combined with tremelimumab (anticytotoxic T-lymphocyte–associated antigen-4) in pretreated patients with extensive-stage SCLC. ADRIATIC, a phase III, randomized, double-blind, placebo-controlled, multicenter, global study ( ClinicalTrials.gov identifier, NCT03703297), is designed to investigate the efficacy of durvalumab, with or without tremelimumab, as consolidation therapy for patients with LS-SCLC without disease progression after cCRT. Approximately 600 patients with documented histologic or cytologic LS-SCLC, World Health Organization/Eastern Cooperative Oncology Group performance status 0 or 1, and no progression after 4 cycles of cCRT will be randomized (1:1:1) to treatment (durvalumab 1500 mg plus placebo every 4 weeks [q4w] for 4 cycles, followed by durvalumab 1500 mg q4w; durvalumab 1500 mg plus tremelimumab 75 mg q4w for 4 cycles, followed by durvalumab 1500 mg q4w; or dual placebo q4w for 4 cycles, followed by single placebo q4w) within 1 to 42 days of completing cCRT, stratified by stage and receipt of prophylactic brain irradiation. The primary endpoints are progression-free survival and overall survival. The secondary endpoints are overall survival and progression-free survival rates, objective response rate, and safety and tolerability. Recruitment began in September 2018. |
| Databáze: | OpenAIRE |
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