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Spots Global Cancer Trial Database for Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Birmingham, Alabama, United States

Research Site, Scottsdale, Arizona, United States

Research Site, Rogers, Arkansas, United States

Research Site, Santa Monica, California, United States

Research Site, New Haven, Connecticut, United States

Research Site, Athens, Georgia, United States

Research Site, Fort Wayne, Indiana, United States

Research Site, Muncie, Indiana, United States

Research Site, Leawood, Kansas, United States

Research Site, Wichita, Kansas, United States

Research Site, Paducah, Kentucky, United States

Research Site, Grand Rapids, Michigan, United States

Research Site, Mineola, New York, United States

Research Site, Cleveland, Ohio, United States

Research Site, Columbus, Ohio, United States

Research Site, Harrisburg, Pennsylvania, United States

Research Site, Sioux Falls, South Dakota, United States

Research Site, Nashville, Tennessee, United States

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

Research Site, São Paulo, , Brazil

Research Site, Panagyurishte, , Bulgaria

Research Site, Plovdiv, , Bulgaria

Research Site, Plovdiv, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Varna, , Bulgaria

Research Site, Beijing, , China

Research Site, Beijing, , China

Research Site, Beijing, , China

Research Site, Bengbu, , China

Research Site, Changchun, , China

Research Site, Changsha, , China

Research Site, Chengdu, , China

Research Site, ChongQing, , China

Research Site, Hangzhou, , China

Research Site, Hangzhou, , China

Research Site, Hangzhou, , China

Research Site, Hefei, , China

Research Site, Nanchang, , China

Research Site, Nanjing, , China

Research Site, Nanjing, , China

Research Site, Shanghai, , China

Research Site, Shanghai, , China

Research Site, Shenyang, , China

Research Site, Wenzhou, , China

Research Site, Wuhan, , China

Research Site, Wuhan, , China

Research Site, Xi'an, , China

Research Site, Xi'an, , China

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

Research Site, Praha, , Czechia

Research Site, Avignon Cedex 09, , France

Research Site, Brest Cedex, , France

Research Site, Creteil, , France

Research Site, La Tronche, , France

Research Site, Pierre Benite Cedex, , France

Research Site, Rennes Cedex 09, , France

Research Site, Aachen, , Germany

Research Site, Berlin, , Germany

Research Site, Gauting, , Germany

Research Site, Gera, , Germany

Research Site, Hamburg, , Germany

Research Site, Heidelberg, , Germany

Research Site, Mainz, , Germany

Research Site, Regensburg, , Germany

Research Site, Budapest, , Hungary

Research Site, Budapest, , Hungary

Research Site, Budapest, , Hungary

Research Site, Budapest, , Hungary

Research Site, Deszk, , Hungary

Research Site, Gyula, , Hungary

Research Site, Kaposvár, , Hungary

Research Site, Kecskemét, , Hungary

Research Site, Miskolc, , Hungary

Research Site, Pécs, , Hungary

Research Site, Székesfehérvár, , Hungary

Research Site, Jerusalem, , Israel

Research Site, Kfar Saba, , Israel

Research Site, Petah Tikva, , Israel

Research Site, Ramat Gan, , Israel

Research Site, Bergamo, , Italy

Research Site, Meldola, , Italy

Research Site, Milano, , Italy

Research Site, Palermo, , Italy

Research Site, Roma, , Italy

Research Site, Terni, , Italy

Research Site, Chuo-ku, , Japan

Research Site, Fukuoka-shi, , Japan

Research Site, Fukushima-shi, , Japan

Research Site, Himeji-shi, , Japan

Research Site, Iwakuni-shi, , Japan

Research Site, Kashiwa, , Japan

Research Site, Koto-ku, , Japan

Research Site, Kurume-shi, , Japan

Research Site, Kyoto, , Japan

Research Site, Matsuyama-shi, , Japan

Research Site, Nagoya-shi, , Japan

Research Site, Nagoya-shi, , Japan

Research Site, Okayama-shi, , Japan

Research Site, Osakasayama, , Japan

Research Site, Sakai-shi, , Japan

Research Site, Tokushima-shi, , Japan

Research Site, Ube-shi, , Japan

Research Site, Yokohama-shi, , Japan

Research Site, Yokohama-shi, , Japan

Research Site, Changwon, , Korea, Republic of

Research Site, Cheongju-si, , Korea, Republic of

Research Site, Daegu, , Korea, Republic of

Research Site, Incheon, , Korea, Republic of

Research Site, Jinju-si, , Korea, Republic of

Research Site, Seongnam-si, , Korea, Republic of

Research Site, Seongnam-Si, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Amsterdam, , Netherlands

Research Site, Arnhem, , Netherlands

Research Site, Groningen, , Netherlands

Research Site, Hengelo, , Netherlands

Research Site, Maastricht, , Netherlands

Research Site, Rotterdam, , Netherlands

Research Site, Bialystok, , Poland

Research Site, Białystok, , Poland

Research Site, Lublin, , Poland

Research Site, Olsztyn, , Poland

Research Site, Warszawa, , Poland

Research Site, Cluj Napoca, , Romania

Research Site, Floresti, , Romania

Research Site, Suceava, , Romania

Research Site, Moscow, , Russian Federation

Research Site, Omsk, , Russian Federation

Research Site, Rostov-on-Don, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Saint-Petersburg, , Russian Federation

Research Site, Sankt-Peterburg, , Russian Federation

Research Site, St. Petersburg, , Russian Federation

Research Site, Ufa, , Russian Federation

Research Site, Banska Bystrica, , Slovakia

Research Site, Bardejov, , Slovakia

Research Site, Bratislava, , Slovakia

Research Site, Bratislava, , Slovakia

Research Site, Kosice, , Slovakia

Research Site, Nove Zamky, , Slovakia

Research Site, Trnava, , Slovakia

Research Site, A Coruña, , Spain

Research Site, Badajoz, , Spain

Research Site, Badalona, , Spain

Research Site, Barcelona, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Santander, , Spain

Research Site, Valencia, , Spain

Research Site, Zaragoza, , Spain

Research Site, Changhua, , Taiwan

Research Site, Kaohsiung City, , Taiwan

Research Site, Kaohsiung, , Taiwan

Research Site, Taichung, , Taiwan

Research Site, Taichung, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Ankara, , Turkey

Research Site, Ankara, , Turkey

Research Site, Edirne, , Turkey

Research Site, Istanbul, , Turkey

Research Site, Izmir, , Turkey

Research Site, Izmir, , Turkey

Research Site, Dnipro, , Ukraine

Research Site, Ivano-Frankivsk, , Ukraine

Research Site, Kirovohrad, , Ukraine

Research Site, Kryvyi Rih, , Ukraine

Research Site, Kyiv, , Ukraine

Research Site, Kyiv, , Ukraine

Research Site, Lviv, , Ukraine

Research Site, Odesa, , Ukraine

Research Site, Sumy, , Ukraine

Research Site, Vinnytsia, , Ukraine

Research Site, Zaporizhzhia, , Ukraine

Contact Details

Name: Haiyi Jiang, M.D.

Affiliation: AstraZeneca

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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