Lung Cancer Clinical Trial

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Summary

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.

4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.

Exclusion criteria:

Extensive-stage SCLC
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Active infection including tuberculosis, HIV, hepatitis B and C
Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

730

Study ID:

NCT03703297

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 182 Locations for this study

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Tucson Arizona, 85715, United States
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Santa Rosa California, 95403, United States
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New Haven Connecticut, 06510, United States
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Fort Myers Florida, 33901, United States
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Orange City Florida, 32763, United States
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Saint Petersburg Florida, 33705, United States
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Marietta Georgia, 30060, United States
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Hines Illinois, 60141, United States
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Fort Wayne Indiana, 46804, United States
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Muncie Indiana, 47303, United States
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Lexington Kentucky, 40536, United States
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Annapolis Maryland, 21401, United States
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Baltimore Maryland, 21287, United States
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Towson Maryland, 21204, United States
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Boston Massachusetts, 02114, United States
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Detroit Michigan, 48201, United States
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Grand Rapids Michigan, 49503, United States
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Minneapolis Minnesota, 55407, United States
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Summit New Jersey, 07902, United States
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New Hyde Park New York, 11042, United States
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Chapel Hill North Carolina, 27599, United States
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Portland Oregon, 97239, United States
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Philadelphia Pennsylvania, 19111, United States
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Pittsburgh Pennsylvania, 15212, United States
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Sioux Falls South Dakota, 57104, United States
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Chattanooga Tennessee, 37404, United States
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Nashville Tennessee, 37203, United States
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Nashville Tennessee, 37232, United States
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Dallas Texas, 75390, United States
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Kennewick Washington, 99336, United States
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Tacoma Washington, 98405, United States
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Charleston West Virginia, 25304, United States
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Huntington West Virginia, 25701, United States
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Milwaukee Wisconsin, 53226, United States
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Caba , C1012, Argentina
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Caba , C1280, Argentina
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Ciudadela , 1702, Argentina
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Córdoba , X5004, Argentina
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La Plata , 1900, Argentina
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Mar del Plata , 7600, Argentina
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Rosario , 2000, Argentina
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San Salvador de Jujuy , 4600, Argentina
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Aalst , 9300, Belgium
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Anderlecht , 1070, Belgium
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Bruxelles , 1200, Belgium
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Hasselt , 3500, Belgium
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Roeselare , 8800, Belgium
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Edmonton Alberta, T6G 1, Canada
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Toronto CA, M5G 2, Canada
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Winnipeg Manitoba, R3E 0, Canada
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Hamilton Ontario, L8V 5, Canada
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London Ontario, N6A 5, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Montreal Quebec, H4A 3, Canada
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Beijing , 10002, China
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Beijing , 10003, China
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Beijing , 10014, China
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Beijing , 10019, China
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Beijing , 10073, China
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Bengbu , 23306, China
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Changchun , 13000, China
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Changsha , 41001, China
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Chengdu , 61004, China
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Chongqing , 40003, China
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Chongqing , 40004, China
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Fuzhou , 35001, China
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Hangzhou , 31000, China
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Hefei , 23060, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shenyang , 11000, China
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Shenyang , 11004, China
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Tianjin , 30006, China
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Wuhan , 43001, China
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Wuhan , 43002, China
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Wuhan , 43003, China
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Yangzhou , 22500, China
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Zhengzhou , 45000, China
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Brno , 639 0, Czechia
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Olomouc , 775 2, Czechia
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Ostrava , 703 0, Czechia
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Praha 2 , 128 0, Czechia
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Praha , 140 5, Czechia
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Berlin , 12351, Germany
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Freiburg , 79106, Germany
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Gauting , 82131, Germany
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Gerlingen , 70839, Germany
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Heidelberg , 69126, Germany
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Köln , 51109, Germany
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Mainz , 55131, Germany
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Münster , 48149, Germany
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Oldenburg , 26121, Germany
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Regensburg , 93053, Germany
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Wuerzburg , 97080, Germany
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Bengaluru , 56007, India
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Gurgaon , 12200, India
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Brescia , 25123, Italy
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Milano , 20133, Italy
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Milano , 20141, Italy
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Orbassano , 10043, Italy
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Parma , 43126, Italy
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Roma , 00100, Italy
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Rozzano , 20089, Italy
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Terni , 05100, Italy
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Bunkyo-ku , 160-0, Japan
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Chuo-ku , 104-0, Japan
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Fukuoka-shi , 812-8, Japan
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Iwakuni-shi , 740-8, Japan
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Kashiwa , 277-8, Japan
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Koto-ku , 135-8, Japan
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Kurume-shi , 830-0, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya-shi , 466-8, Japan
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Niigata-shi , 951-8, Japan
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Osakasayama , 589-8, Japan
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Sakai-shi , 591-8, Japan
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Sapporo-shi , 003-0, Japan
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Sendai-shi , 980-0, Japan
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Sunto-gun , 411-8, Japan
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Tokushima-shi , 770-8, Japan
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Ube-shi , 755-0, Japan
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Changwon-si , 51353, Korea, Republic of
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Cheongju-si , 28644, Korea, Republic of
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Daegu , 42415, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Gyeongsangnam-do , 52727, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Amsterdam , 1081 , Netherlands
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Den Bosch , 5223 , Netherlands
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Groningen , 9713 , Netherlands
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Harderwijk , 3844 , Netherlands
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Hengelo , 7555 , Netherlands
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Gdańsk , 80-21, Poland
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Olsztyn , 10-35, Poland
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Poznań , 60-56, Poland
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Tomaszów Mazowiecki , 97-20, Poland
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Warszawa , 02-78, Poland
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Wroclaw , 53-41, Poland
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Kazan , 42002, Russian Federation
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Kirov , 61002, Russian Federation
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Moscow , 10522, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 12528, Russian Federation
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Obninsk , 24903, Russian Federation
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Omsk , 64401, Russian Federation
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Ufa , 45005, Russian Federation
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Volgograd , 40013, Russian Federation
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Barcelona , 08003, Spain
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Barcelona , 08035, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Oviedo , 33011, Spain
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Sevilla , 41013, Spain
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Valencia , 46026, Spain
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Zaragoza , 50009, Spain
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Hsinchu , 300, Taiwan
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Kaohsiung City , 83301, Taiwan
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Keelung City , 20445, Taiwan
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Taichung , 40705, Taiwan
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Tainan City , 70403, Taiwan
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Tainan , 736, Taiwan
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Taipei , 112, Taiwan
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Taipei , 235, Taiwan
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Taoyuan City , 333, Taiwan
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Yunlin , 640, Taiwan
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Adana , 01060, Turkey
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Ankara , 06230, Turkey
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Ankara , 06280, Turkey
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Antalya , 07059, Turkey
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Edirne , 22030, Turkey
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Istanbul , 34030, Turkey
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Izmir , 35620, Turkey
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Konya , 42080, Turkey
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Samsun , , Turkey
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Manchester , M20 4, United Kingdom
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Truro , TR1 3, United Kingdom
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

730

Study ID:

NCT03703297

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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