Lung Cancer Clinical Trial
Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
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
Full 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 Criteria
Inclusion criteria:
Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
Life expectancy ≥12 weeks at Day 1.
ECOG 0 or 1 at enrolment.
No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
Exclusion criteria:
Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
Active infection including tuberculosis, HIV, hepatitis B anc C
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
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There are 204 Locations for this study
Birmingham Alabama, 35235, United States
Scottsdale Arizona, 85259, United States
Rogers Arkansas, 72758, United States
Santa Monica California, 90404, United States
New Haven Connecticut, 06520, United States
Athens Georgia, 30607, United States
Fort Wayne Indiana, 46804, United States
Muncie Indiana, 47303, United States
Leawood Kansas, 66209, United States
Wichita Kansas, 67214, United States
Paducah Kentucky, 42003, United States
Grand Rapids Michigan, 49503, United States
Mineola New York, 11501, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43219, United States
Harrisburg Pennsylvania, 17109, United States
Sioux Falls South Dakota, 57104, United States
Nashville Tennessee, 37203, United States
Kennewick Washington, 99336, United States
Buenos Aires , C1118, Argentina
Ciudad de Buenos Aires , C1426, Argentina
Mar del Plata , 7600, Argentina
Rosario , 2000, Argentina
San Miguel de Tucuman , T4000, Argentina
Linz , 4021, Austria
Salzburg , 5020, Austria
Wien , 1140, Austria
Wien , 1210, Austria
Barretos , 14784, Brazil
Curitiba , 81520, Brazil
Passo Fundo , 99010, Brazil
Porto Alegre , 91350, Brazil
Ribeirão Preto , 14048, Brazil
Rio de Janeiro , 22793, Brazil
Salvador , 41.95, Brazil
Santo André , 09060, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 03102, Brazil
Panagyurishte , 4500, Bulgaria
Plovdiv , 4000, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1618, Bulgaria
Sofia , 1784, Bulgaria
Varna , 9010, Bulgaria
Beijing , 10014, China
Beijing , 10073, China
Beijing , 10085, China
Bengbu , 23306, China
Changchun , 13002, China
Changsha , 41001, China
Chengdu , 61004, China
ChongQing , 40003, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hefei , 23060, China
Nanchang , 33000, China
Nanjing , 21000, China
Nanjing , 21002, China
Shanghai , 20003, China
Shanghai , 20043, China
Shenyang , 11004, China
Wenzhou , 32500, China
Wuhan , 43002, China
Wuhan , 43003, China
Xi'an , 71003, China
Xi'an , 71006, China
Zhanjiang , 52400, China
Zhengzhou , 45000, China
Zhuhai , 51909, China
Ürümqi , 83000, China
Brno , 639 0, Czechia
Olomouc , 775 2, Czechia
Ostrava - Vitkovice , 703 8, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , CZ-15, Czechia
Praha , 140 5, Czechia
Avignon Cedex 09 , 84918, France
Brest Cedex , 29609, France
Creteil , 94010, France
La Tronche , 38043, France
Pierre Benite Cedex , 69310, France
Rennes Cedex 09 , 35033, France
Aachen , 52074, Germany
Berlin , 13125, Germany
Gauting , 82131, Germany
Gera , 07548, Germany
Hamburg , 20251, Germany
Heidelberg , 69126, Germany
Mainz , 55131, Germany
Regensburg , 93053, Germany
Budapest , 1083, Hungary
Budapest , 1106, Hungary
Budapest , 1121, Hungary
Budapest , 1134, Hungary
Deszk , 6772, Hungary
Gyula , 5700, Hungary
Kaposvár , 7400, Hungary
Kecskemét , 6000, Hungary
Miskolc , 3529, Hungary
Pécs , 7624, Hungary
Székesfehérvár , 8000, Hungary
Jerusalem , 91031, Israel
Kfar Saba , 95847, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52656, Israel
Bergamo , 24127, Italy
Meldola , 47014, Italy
Milano , 20133, Italy
Palermo , 90146, Italy
Roma , 00100, Italy
Terni , 05100, Italy
Chuo-ku , 104-0, Japan
Fukuoka-shi , 812-8, Japan
Fukushima-shi , 960-1, Japan
Himeji-shi , 670-8, Japan
Iwakuni-shi , 740-8, Japan
Kashiwa , 227-8, Japan
Koto-ku , 135-8, Japan
Kurume-shi , 830-0, Japan
Kyoto , 606-8, Japan
Matsuyama-shi , 791-0, Japan
Nagoya-shi , 464-8, Japan
Nagoya-shi , 466-8, Japan
Okayama-shi , 700-8, Japan
Osakasayama , 589-8, Japan
Sakai-shi , 591-8, Japan
Tokushima-shi , 770-8, Japan
Ube-shi , 755-0, Japan
Yokohama-shi , 236-0, Japan
Yokohama-shi , 241-8, Japan
Changwon , 51353, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Daegu , 42415, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jinju-si , 660-7, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seongnam-si , 463-7, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 11074, Korea, Republic of
Amsterdam , 1066 , Netherlands
Arnhem , 6815 , Netherlands
Groningen , 9713 , Netherlands
Hengelo , 7555 , Netherlands
Maastricht , 6202 , Netherlands
Rotterdam , 3015 , Netherlands
Bialystok , 15-02, Poland
Białystok , 15-54, Poland
Lublin , 20-95, Poland
Olsztyn , 10-35, Poland
Warszawa , 02-78, Poland
Cluj Napoca , 40001, Romania
Floresti , 40728, Romania
Suceava , 72023, Romania
Moscow , 10522, Russian Federation
Omsk , 64401, Russian Federation
Rostov-on-Don , 34403, Russian Federation
Saint Petersburg , 19527, Russian Federation
Saint-Petersburg , 19429, Russian Federation
Sankt-Peterburg , 19660, Russian Federation
St. Petersburg , 19775, Russian Federation
Ufa , 45005, Russian Federation
Banska Bystrica , 97517, Slovakia
Bardejov , 085 0, Slovakia
Bratislava , 82606, Slovakia
Bratislava , 833 0, Slovakia
Kosice , 041 9, Slovakia
Nove Zamky , 940 0, Slovakia
Trnava , 91708, Slovakia
A Coruña , 15006, Spain
Badajoz , 06008, Spain
Badalona , 08916, Spain
Barcelona , 08041, Spain
Madrid , 08035, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Santander , 39008, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Changhua , 50006, Taiwan
Kaohsiung City , 83301, Taiwan
Kaohsiung , 82445, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Tainan , 736, Taiwan
Taipei , 11217, Taiwan
Taipei , 235, Taiwan
Ankara , 06230, Turkey
Ankara , , Turkey
Edirne , 22030, Turkey
Istanbul , 34030, Turkey
Izmir , 35100, Turkey
Izmir , 35620, Turkey
Dnipro , 49102, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kirovohrad , 25006, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03022, Ukraine
Kyiv , 03115, Ukraine
Lviv , 79031, Ukraine
Odesa , 65055, Ukraine
Sumy , 40022, Ukraine
Vinnytsia , 21029, Ukraine
Zaporizhzhia , 69040, Ukraine
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