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
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)
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There are 179 Locations for this study
Tucson Arizona, 85715, United States
Santa Rosa California, 95403, United States
New Haven Connecticut, 06510, United States
Fort Myers Florida, 33901, United States
Orange City Florida, 32763, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Hines Illinois, 60141, United States
Fort Wayne Indiana, 46804, United States
Muncie Indiana, 47303, United States
Lexington Kentucky, 40536, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21287, United States
Towson Maryland, 21204, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Grand Rapids Michigan, 49503, United States
Minneapolis Minnesota, 55407, United States
Summit New Jersey, 07902, United States
New Hyde Park New York, 11042, United States
Chapel Hill North Carolina, 27599, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15212, United States
Sioux Falls South Dakota, 57104, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Kennewick Washington, 99336, United States
Tacoma Washington, 98405, United States
Charleston West Virginia, 25304, United States
Huntington West Virginia, 25701, United States
Milwaukee Wisconsin, 53226, United States
Caba , C1012, Argentina
Caba , C1280, Argentina
Córdoba , X5004, Argentina
Mar del Plata , 7600, Argentina
Rosario , 2000, Argentina
Aalst , 9300, Belgium
Anderlecht , 1070, Belgium
Bruxelles , 1200, Belgium
Hasselt , 3500, Belgium
Roeselare , 8800, Belgium
Edmonton Alberta, T6G 1, Canada
Toronto CA, M5G 2, Canada
Winnipeg Manitoba, R3E 0, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H4A 3, Canada
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10014, China
Beijing , 10019, China
Beijing , 10073, China
Bengbu , 23306, China
Changchun , 13000, China
Changsha , 41001, China
Chengdu , 61004, China
Chongqing , 40003, China
Chongqing , 40004, China
Fuzhou , 35001, China
Hangzhou , 31000, China
Hefei , 23060, China
Shanghai , 20003, China
Shanghai , 20003, China
Shenyang , 11000, China
Shenyang , 11004, China
Tianjin , 30006, China
Wuhan , 43001, China
Wuhan , 43002, China
Wuhan , 43003, China
Yangzhou , 22500, China
Zhengzhou , 45000, China
Brno , 639 0, Czechia
Olomouc , 775 2, Czechia
Ostrava , 703 0, Czechia
Praha 2 , 128 0, Czechia
Praha , 140 5, Czechia
Berlin , 12351, Germany
Freiburg , 79106, Germany
Gauting , 82131, Germany
Gerlingen , 70839, Germany
Heidelberg , 69126, Germany
Köln , 51109, Germany
Mainz , 55131, Germany
Münster , 48149, Germany
Oldenburg , 26121, Germany
Regensburg , 93053, Germany
Wuerzburg , 97080, Germany
Bengaluru , 56007, India
Gurgaon , 12200, India
Brescia , 25123, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Orbassano , 10043, Italy
Parma , 43126, Italy
Roma , 00100, Italy
Rozzano , 20089, Italy
Terni , 05100, Italy
Bunkyo-ku , 160-0, Japan
Chuo-ku , 104-0, Japan
Fukuoka-shi , 812-8, Japan
Iwakuni-shi , 740-8, Japan
Kashiwa , 277-8, Japan
Koto-ku , 135-8, Japan
Kurume-shi , 830-0, Japan
Nagoya-shi , 464-8, Japan
Nagoya-shi , 466-8, Japan
Niigata-shi , 951-8, Japan
Osakasayama , 589-8, Japan
Sakai-shi , 591-8, Japan
Sapporo-shi , 003-0, Japan
Sendai-shi , 980-0, Japan
Sunto-gun , 411-8, Japan
Tokushima-shi , 770-8, Japan
Ube-shi , 755-0, Japan
Changwon-si , 51353, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Daegu , 42415, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gyeongsangnam-do , 52727, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Suwon-si , 16499, Korea, Republic of
Amsterdam , 1081 , Netherlands
Den Bosch , 5223 , Netherlands
Groningen , 9713 , Netherlands
Harderwijk , 3844 , Netherlands
Hengelo , 7555 , Netherlands
Gdańsk , 80-21, Poland
Olsztyn , 10-35, Poland
Poznań , 60-56, Poland
Tomaszów Mazowiecki , 97-20, Poland
Warszawa , 02-78, Poland
Wroclaw , 53-41, Poland
Kazan , 42002, Russian Federation
Kirov , 61002, Russian Federation
Moscow , 10522, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12528, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Ufa , 45005, Russian Federation
Volgograd , 40013, Russian Federation
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Oviedo , 33011, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Hsinchu , 300, Taiwan
Kaohsiung City , 83301, Taiwan
Keelung City , 20445, Taiwan
Taichung , 40705, Taiwan
Tainan City , 70403, Taiwan
Tainan , 736, Taiwan
Taipei , 112, Taiwan
Taipei , 235, Taiwan
Taoyuan City , 333, Taiwan
Yunlin , 640, Taiwan
Adana , 01060, Turkey
Ankara , 06230, Turkey
Ankara , 06280, Turkey
Antalya , 07059, Turkey
Edirne , 22030, Turkey
Istanbul , 34030, Turkey
Izmir , 35620, Turkey
Konya , 42080, Turkey
Samsun , , Turkey
Manchester , M20 4, United Kingdom
Truro , TR1 3, United Kingdom
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
Ho Chi Minh , 70000, Vietnam
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