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

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

987

Study ID:

NCT03043872

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 203 Locations for this study

See Locations Near You

Research Site
Birmingham Alabama, 35235, United States
Research Site
Scottsdale Arizona, 85259, United States
Research Site
Rogers Arkansas, 72758, United States
Research Site
Santa Monica California, 90404, United States
Research Site
New Haven Connecticut, 06520, United States
Research Site
Athens Georgia, 30607, United States
Research Site
Fort Wayne Indiana, 46804, United States
Research Site
Muncie Indiana, 47303, United States
Research Site
Leawood Kansas, 66209, United States
Research Site
Wichita Kansas, 67214, United States
Research Site
Paducah Kentucky, 42003, United States
Research Site
Grand Rapids Michigan, 49503, United States
Research Site
Mineola New York, 11501, United States
Research Site
Cleveland Ohio, 44106, United States
Research Site
Columbus Ohio, 43219, United States
Research Site
Harrisburg Pennsylvania, 17109, United States
Research Site
Sioux Falls South Dakota, 57104, United States
Research Site
Nashville Tennessee, 37203, United States
Research Site
Kennewick Washington, 99336, United States
Research Site
Buenos Aires , C1118, Argentina
Research Site
Ciudad de Buenos Aires , C1426, Argentina
Research Site
Mar del Plata , 7600, Argentina
Research Site
Rosario , 2000, Argentina
Research Site
San Miguel de Tucuman , T4000, Argentina
Research Site
Linz , 4021, Austria
Research Site
Salzburg , 5020, Austria
Research Site
Wien , 1140, Austria
Research Site
Wien , 1210, Austria
Research Site
Barretos , 14784, Brazil
Research Site
Curitiba , 81520, Brazil
Research Site
Passo Fundo , 99010, Brazil
Research Site
Porto Alegre , 91350, Brazil
Research Site
Ribeirão Preto , 14048, Brazil
Research Site
Rio de Janeiro , 22793, Brazil
Research Site
Salvador , 41.95, Brazil
Research Site
Santo André , 09060, Brazil
Research Site
São José do Rio Preto , 15090, Brazil
Research Site
São Paulo , 03102, Brazil
Research Site
Panagyurishte , 4500, Bulgaria
Research Site
Plovdiv , 4000, Bulgaria
Research Site
Plovdiv , 4004, Bulgaria
Research Site
Sofia , 1330, Bulgaria
Research Site
Sofia , 1431, Bulgaria
Research Site
Sofia , 1618, Bulgaria
Research Site
Sofia , 1784, Bulgaria
Research Site
Varna , 9010, Bulgaria
Research Site
Beijing , 10014, China
Research Site
Beijing , 10073, China
Research Site
Beijing , 10085, China
Research Site
Bengbu , 23306, China
Research Site
Changchun , 13002, China
Research Site
Changsha , 41001, China
Research Site
Chengdu , 61004, China
Research Site
ChongQing , 40003, China
Research Site
Hangzhou , 31000, China
Research Site
Hangzhou , 31000, China
Research Site
Hangzhou , 31000, China
Research Site
Hefei , 23060, China
Research Site
Nanchang , 33000, China
Research Site
Nanjing , 21000, China
Research Site
Nanjing , 21002, China
Research Site
Shanghai , 20003, China
Research Site
Shanghai , 20043, China
Research Site
Shenyang , 11004, China
Research Site
Wenzhou , 32500, China
Research Site
Wuhan , 43002, China
Research Site
Wuhan , 43003, China
Research Site
Xi'an , 71003, China
Research Site
Xi'an , 71006, China
Research Site
Zhanjiang , 52400, China
Research Site
Zhengzhou , 45000, China
Research Site
Zhuhai , 51909, China
Research Site
Ürümqi , 83000, China
Research Site
Brno , 639 0, Czechia
Research Site
Olomouc , 775 2, Czechia
Research Site
Ostrava - Vitkovice , 703 8, Czechia
Research Site
Praha 2 , 128 0, Czechia
Research Site
Praha 5 , CZ-15, Czechia
Research Site
Praha , 140 5, Czechia
Research Site
Avignon Cedex 09 , 84918, France
Research Site
Brest Cedex , 29609, France
Research Site
Creteil , 94010, France
Research Site
La Tronche , 38043, France
Research Site
Pierre Benite Cedex , 69310, France
Research Site
Rennes Cedex 09 , 35033, France
Research Site
Aachen , 52074, Germany
Research Site
Berlin , 13125, Germany
Research Site
Gauting , 82131, Germany
Research Site
Gera , 07548, Germany
Research Site
Hamburg , 20251, Germany
Research Site
Heidelberg , 69126, Germany
Research Site
Mainz , 55131, Germany
Research Site
Regensburg , 93053, Germany
Research Site
Budapest , 1083, Hungary
Research Site
Budapest , 1106, Hungary
Research Site
Budapest , 1121, Hungary
Research Site
Budapest , 1134, Hungary
Research Site
Deszk , 6772, Hungary
Research Site
Gyula , 5700, Hungary
Research Site
Kaposvár , 7400, Hungary
Research Site
Kecskemét , 6000, Hungary
Research Site
Miskolc , 3529, Hungary
Research Site
Pécs , 7624, Hungary
Research Site
Székesfehérvár , 8000, Hungary
Research Site
Jerusalem , 91031, Israel
Research Site
Kfar Saba , 95847, Israel
Research Site
Petah Tikva , 49100, Israel
Research Site
Ramat Gan , 52656, Israel
Research Site
Bergamo , 24127, Italy
Research Site
Meldola , 47014, Italy
Research Site
Milano , 20133, Italy
Research Site
Palermo , 90146, Italy
Research Site
Roma , 00100, Italy
Research Site
Terni , 05100, Italy
Research Site
Chuo-ku , 104-0, Japan
Research Site
Fukuoka-shi , 812-8, Japan
Research Site
Fukushima-shi , 960-1, Japan
Research Site
Himeji-shi , 670-8, Japan
Research Site
Iwakuni-shi , 740-8, Japan
Research Site
Kashiwa , 227-8, Japan
Research Site
Koto-ku , 135-8, Japan
Research Site
Kurume-shi , 830-0, Japan
Research Site
Kyoto , 606-8, Japan
Research Site
Matsuyama-shi , 791-0, Japan
Research Site
Nagoya-shi , 464-8, Japan
Research Site
Nagoya-shi , 466-8, Japan
Research Site
Okayama-shi , 700-8, Japan
Research Site
Osakasayama , 589-8, Japan
Research Site
Sakai-shi , 591-8, Japan
Research Site
Tokushima-shi , 770-8, Japan
Research Site
Ube-shi , 755-0, Japan
Research Site
Yokohama-shi , 236-0, Japan
Research Site
Yokohama-shi , 241-8, Japan
Research Site
Changwon , 51353, Korea, Republic of
Research Site
Cheongju-si , 28644, Korea, Republic of
Research Site
Daegu , 42415, Korea, Republic of
Research Site
Incheon , 405-7, Korea, Republic of
Research Site
Jinju-si , 660-7, Korea, Republic of
Research Site
Seongnam-si , 13620, Korea, Republic of
Research Site
Seongnam-si , 463-7, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Seoul , 11074, Korea, Republic of
Research Site
Amsterdam , 1066 , Netherlands
Research Site
Arnhem , 6815 , Netherlands
Research Site
Groningen , 9713 , Netherlands
Research Site
Hengelo , 7555 , Netherlands
Research Site
Maastricht , 6202 , Netherlands
Research Site
Rotterdam , 3015 , Netherlands
Research Site
Bialystok , 15-02, Poland
Research Site
Białystok , 15-54, Poland
Research Site
Lublin , 20-95, Poland
Research Site
Olsztyn , 10-35, Poland
Research Site
Warszawa , 02-78, Poland
Research Site
Cluj Napoca , 40001, Romania
Research Site
Floresti , 40728, Romania
Research Site
Suceava , 72023, Romania
Research Site
Moscow , 10522, Russian Federation
Research Site
Omsk , 64401, Russian Federation
Research Site
Rostov-on-Don , 34403, Russian Federation
Research Site
Saint Petersburg , 19527, Russian Federation
Research Site
Saint-Petersburg , 19429, Russian Federation
Research Site
St. Petersburg , 19775, Russian Federation
Research Site
Ufa , 45005, Russian Federation
Research Site
Banska Bystrica , 97517, Slovakia
Research Site
Bardejov , 085 0, Slovakia
Research Site
Bratislava , 82606, Slovakia
Research Site
Bratislava , 833 0, Slovakia
Research Site
Kosice , 041 9, Slovakia
Research Site
Nove Zamky , 940 0, Slovakia
Research Site
Trnava , 91708, Slovakia
Research Site
A Coruña , 15006, Spain
Research Site
Badajoz , 06008, Spain
Research Site
Badalona , 08916, Spain
Research Site
Barcelona , 08041, Spain
Research Site
Madrid , 08035, Spain
Research Site
Madrid , 28040, Spain
Research Site
Madrid , 28041, Spain
Research Site
Santander , 39008, Spain
Research Site
Valencia , 46010, Spain
Research Site
Zaragoza , 50009, Spain
Research Site
Changhua , 50006, Taiwan
Research Site
Kaohsiung City , 83301, Taiwan
Research Site
Kaohsiung , 82445, Taiwan
Research Site
Taichung , 40447, Taiwan
Research Site
Taichung , 40705, Taiwan
Research Site
Tainan , 704, Taiwan
Research Site
Tainan , 736, Taiwan
Research Site
Taipei , 11217, Taiwan
Research Site
Taipei , 235, Taiwan
Research Site
Ankara , 06230, Turkey
Research Site
Ankara , , Turkey
Research Site
Edirne , 22030, Turkey
Research Site
Istanbul , 34030, Turkey
Research Site
Izmir , 35100, Turkey
Research Site
Izmir , 35620, Turkey
Research Site
Dnipro , 49102, Ukraine
Research Site
Ivano-Frankivsk , 76018, Ukraine
Research Site
Kirovohrad , 25006, Ukraine
Research Site
Kryvyi Rih , 50048, Ukraine
Research Site
Kyiv , 03022, Ukraine
Research Site
Kyiv , 03115, Ukraine
Research Site
Lviv , 79031, Ukraine
Research Site
Odesa , 65055, Ukraine
Research Site
Sumy , 40022, Ukraine
Research Site
Vinnytsia , 21029, Ukraine
Research Site
Zaporizhzhia , 69040, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

987

Study ID:

NCT03043872

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.