Lung Cancer Clinical Trial

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Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

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Summary

This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

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Full Description

Patients who have no evidence of disease recurrence confirmed by CT and/or MRI and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab + Standard of care (SoC) chemotherapy or placebo + Standard of care (SoC) chemotherapy arm.

The primary objective of this study is to assess the efficacy of durvalumab +SoC chemotherapy compared to placebo+ SoC chemotherapy in terms of DFS measured in MRD+ patients.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Capable of giving signed informed consent, which includes a mandatory genetic informed consent and compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and study protocol
Age ≥18 years at the time of screening
Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease
Complete resection of the primary NSCLC

Exclusion Criteria:

Postoperative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence
EGFR-mutant and/or ALK-translocation
Mixed small cell and NSCLC histology
Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

89

Study ID:

NCT04385368

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 142 Locations for this study

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Birmingham Alabama, 35294, United States
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Long Beach California, 90806, United States
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Santa Rosa California, 95403, United States
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West Hollywood California, 90048, United States
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Miami Florida, 33136, United States
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Silver Spring Maryland, 20910, United States
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Minneapolis Minnesota, 55407, United States
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Lincoln Nebraska, 68510, United States
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Albuquerque New Mexico, 87131, United States
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New York New York, 10032, United States
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Durham North Carolina, 27710, United States
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Spartanburg South Carolina, 29303, United States
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Sioux Falls South Dakota, 57105, United States
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Houston Texas, 77090, United States
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Seattle Washington, 98108, United States
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Rosario , S2000, Argentina
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Camperdown , 2050, Australia
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St Leonards , 2065, Australia
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Aalst , 9300, Belgium
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Bruxelles , 1200, Belgium
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Hasselt , 3500, Belgium
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Leuven , 3000, Belgium
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Roeselare , 8800, Belgium
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Belo Horizonte , 30110, Brazil
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Blumenau , 89010, Brazil
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Fortaleza , 60336, Brazil
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Ibirapuera , 04501, Brazil
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São José do Rio Preto , 15090, Brazil
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Vitoria , 29043, Brazil
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Panagyurishte , 4500, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1618, Bulgaria
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Victoria British Columbia, V8R 6, Canada
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Saint John New Brunswick, E2L 4, Canada
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Kingston Ontario, K7L 2, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H4A 3, Canada
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Olomouc , 77900, 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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Copenhagen , 2100, Denmark
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Odense C , 5000, Denmark
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Bordeaux , 33000, France
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Marseille , 13915, France
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Saint Herblain , 44805, France
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Strasbourg Cedex , 67091, France
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Toulouse , 31000, France
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Villejuif Cedex , 94805, France
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Esslingen , 73730, Germany
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Gauting , 82131, Germany
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Regensburg , 93049, Germany
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Athens , 11526, Greece
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Athens , 11527, Greece
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Heraklion , 711 1, Greece
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Holargos, Athens , 155 6, Greece
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Thessaloniki , 54645, Greece
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Hong Kong , , Hong Kong
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Budapest , 1121, Hungary
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Gyöngyös - Mátraháza , 3200, Hungary
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Győr , 9024, Hungary
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Szolnok , 5004, Hungary
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Törökbálint , 2045, Hungary
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Bengaluru , 56009, India
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Mohali , 16005, India
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New Dehli , 11002, India
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Haifa , 31096, Israel
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Kfar Saba , 95847, Israel
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Petah Tikva , 49100, Israel
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Ramat Gan , 52656, Israel
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Meldola , 47014, Italy
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Monza , 20900, Italy
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Orbassano , 10043, Italy
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Roma , 00144, Italy
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Rozzano , 20089, Italy
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Akashi-shi , 673-8, Japan
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Bunkyo-ku , 113-8, Japan
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Hiroshima-shi , 734-8, Japan
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Kashiwa , 277-8, Japan
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Koto-ku , 135-8, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya-shi , 466-8, Japan
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Osaka-shi , 534-0, Japan
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Osaka-shi , 541-8, Japan
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Sakai-shi , 591-8, Japan
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Sendai-shi , 980-0, Japan
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Sunto-gun , 411-8, Japan
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Yokohama-shi , 241-8, Japan
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Cheongju-si , 28644, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Suwon-si , 16247, Korea, Republic of
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Culiacan , 80040, Mexico
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Mexico , 01710, Mexico
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Breda , 4818 , Netherlands
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Maastricht , 6202 , Netherlands
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Zwolle , 8025 , Netherlands
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Bellavista , CALLA, Peru
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Lima , L41, Peru
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Lima , Lima , Peru
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Lima , LIMA , Peru
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Trujillo , , Peru
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Bydgoszcz , 85-79, Poland
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Gdańsk , 80-21, Poland
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Tomaszów Mazowiecki , 97-20, Poland
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Warszawa , 02-78, Poland
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Wrocław , 53-41, Poland
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Floresti , 40728, Romania
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Kazan , 42002, Russian Federation
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Krasnodar , 35008, Russian Federation
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Krasnoyarsk , 66013, Russian Federation
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Moscow , 10522, Russian Federation
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Moscow , 11547, Russian Federation
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Novosibirsk , 63010, Russian Federation
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Saint Petersburg , 19103, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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Singapore , 16961, Singapore
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Barcelona , 08041, Spain
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Madrid , 28041, Spain
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Málaga , 29010, Spain
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Oviedo , 33011, Spain
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Pamplona , 31008, Spain
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Santiago De Compostela (A Coruña) , 15706, Spain
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Stockholm , 17176, Sweden
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Lausanne , 1011, Switzerland
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Zürich , CH-80, Switzerland
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Chiayi , 613, Taiwan
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Taichung , 40201, Taiwan
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Taipei 112 , , Taiwan
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Taipei City , 114, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 10449, Taiwan
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Taipei , 235, Taiwan
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Tao-Yuan , , Taiwan
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Bangkok , 10300, Thailand
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Bangkok , 10330, Thailand
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Chiang Mai , 50200, Thailand
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Khon Kaen , 40002, Thailand
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Phisanulok , 65000, Thailand
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Adana , 01120, Turkey
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Ankara , 06010, Turkey
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Istanbul , 34010, Turkey
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Istanbul , 34214, Turkey
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Malatya , 44100, Turkey
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

89

Study ID:

NCT04385368

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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