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Brief Title: Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Official Title: A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)
Study ID: NCT03043872
Brief Summary: This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Detailed Description: Primary objective of this study is to assess the efficacy of durvalumab + tremelimumab + EP treatment compared with EP and the efficacy of durvalumab + EP treatment compared with EP in terms of OS. All patients will be randomized in a 1:1:1 ratio in a stratified manner according to the planned platinum-based therapy for Cycle 1 (cisplatin or carboplatin) to receive treatment with durvalumab + tremelimumab + EP (Arm 1), durvalumab + EP (Arm 2), or standard of care- EP (Arm 3). Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if clinically indicated, at the Investigators' discretion.Patients who have discontinued treatment due to toxicity or symptomatic deterioration, clinical progression, or who have commenced subsequent anticancer therapy will be followed up until confirmed disease progression and for survival. Targeted population are adult patients (aged ≥18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC \[T any, N any,M1 a/b\]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1. Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week from the date of randomization, at Week 12 ±1 week from the date of randomization, and then every 8 weeks ±1 week until confirmed objective disease progression. An independent data monitoring committee (IDMC) comprised of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule of durvalumab ± tremelimumab in combination with platinum based chemotherapy at two early stages of enrolment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Birmingham, Alabama, United States
Research Site, Scottsdale, Arizona, United States
Research Site, Rogers, Arkansas, United States
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Research Site, Fort Wayne, Indiana, United States
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Research Site, Leawood, Kansas, United States
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Research Site, Kennewick, Washington, United States
Research Site, Buenos Aires, , Argentina
Research Site, Ciudad de Buenos Aires, , Argentina
Research Site, Mar del Plata, , Argentina
Research Site, Rosario, , Argentina
Research Site, San Miguel de Tucuman, , Argentina
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Barretos, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Passo Fundo, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Ribeirão Preto, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Salvador, , Brazil
Research Site, Santo André, , Brazil
Research Site, São José do Rio Preto, , Brazil
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Research Site, Panagyurishte, , Bulgaria
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Research Site, Nanjing, , China
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Research Site, Xi'an, , China
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Research Site, Zhanjiang, , China
Research Site, Zhengzhou, , China
Research Site, Zhuhai, , China
Research Site, Ürümqi, , China
Research Site, Brno, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Ostrava - Vitkovice, , Czechia
Research Site, Praha 2, , Czechia
Research Site, Praha 5, , Czechia
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Research Site, Avignon Cedex 09, , France
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Research Site, Chuo-ku, , Japan
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Research Site, Kyoto, , Japan
Research Site, Matsuyama-shi, , Japan
Research Site, Nagoya-shi, , Japan
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Research Site, Okayama-shi, , Japan
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Research Site, Changwon, , Korea, Republic of
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Research Site, Incheon, , Korea, Republic of
Research Site, Jinju-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
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Research Site, Seoul, , Korea, Republic of
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Research Site, Amsterdam, , Netherlands
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Research Site, Groningen, , Netherlands
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Research Site, Rotterdam, , Netherlands
Research Site, Bialystok, , Poland
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Research Site, Cluj Napoca, , Romania
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Research Site, Moscow, , Russian Federation
Research Site, Omsk, , Russian Federation
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Research Site, Saint Petersburg, , Russian Federation
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Research Site, St. Petersburg, , Russian Federation
Research Site, Ufa, , Russian Federation
Research Site, Banska Bystrica, , Slovakia
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Name: Haiyi Jiang, M.D.
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR