Lung Cancer Clinical Trial

A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Summary

A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

View Full Description

Full Description

This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Aged at least 18 years.
Documented evidence of NSCLC (stage IIIB/IV disease)
Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
World Health Organisation (WHO) Performance Status of 0 or 1
Estimated life expectancy of more than 12 weeks
Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria:

Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
Active or prior autoimmune disease or history of immunodeficiency
Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

446

Study ID:

NCT02087423

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 136 Locations for this study

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Goodyear Arizona, , United States
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Santa Rosa California, 95403, United States
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New Haven Connecticut, 06511, United States
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Port Saint Lucie Florida, 34952, United States
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Tampa Florida, 33612, United States
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Lawrenceville Georgia, 30046, United States
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Waterloo Iowa, 50701, United States
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Topeka Kansas, 66606, United States
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Bethesda Maryland, 20817, United States
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Burlington Massachusetts, 01803, United States
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Worcester Massachusetts, 01608, United States
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Saint Louis Park Minnesota, 55426, United States
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Bronx New York, 10461, United States
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New York New York, 10011, United States
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New York New York, 10016, United States
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New York New York, 10032, United States
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New York New York, 10065, United States
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Huntersville North Carolina, 28078, United States
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Bismarck North Dakota, 58501, United States
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Fargo North Dakota, 58102, United States
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Blue Ash Ohio, 45242, United States
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Canton Ohio, 44718, United States
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Middletown Ohio, 45042, United States
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Chattanooga Tennessee, 37404, United States
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Nashville Tennessee, 37203, United States
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Fort Worth Texas, 76104, United States
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Spokane Washington, 99208, United States
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Wenatchee Washington, 98801, United States
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Wien , 1145, Austria
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Brussel , 1000, Belgium
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Gent , 9000, Belgium
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Gilly , 6060, Belgium
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Kortrijk , 8500, Belgium
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Leuven , 3000, Belgium
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Liège , 4000, Belgium
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Hamilton Ontario, L8V 5, Canada
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London Ontario, N6A 4, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Regina Saskatchewan, S4T 7, Canada
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Brno , 656 5, Czechia
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Praha 5 , 150 0, Czechia
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Praha 8 , 180 8, Czechia
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Praha , 14059, Czechia
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Bordeaux Cedex , 33076, France
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Brest Cedex , 29609, France
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Creteil , 94010, France
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Dijon , 21034, France
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Le Mans Cedex 02 , 72015, France
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Marseille , 13015, France
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Pessac , 33600, France
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Rennes Cedex 09 , 35033, France
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Saint Herblain Cedex , 44805, France
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Toulouse Cedex 9 , 31059, France
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Berlin , 10967, Germany
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Berlin , , Germany
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Borstel , 23845, Germany
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Dortmund , 44263, Germany
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Frankfurt am Main , 60590, Germany
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Freiburg , 79106, Germany
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Grosshansdorf , 22927, Germany
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Hamburg , 20251, Germany
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Heidelberg , 69126, Germany
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Köln , 50924, Germany
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Budapest , 1083, Hungary
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Budapest , 1121, Hungary
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Győr , 9024, Hungary
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Szolnok , 5000, Hungary
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Tatabánya , 2800, Hungary
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Törökbálint , 2045, Hungary
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Candiolo , 10060, Italy
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Catania , 95125, Italy
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Milano , 20133, Italy
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Monza , 20900, Italy
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Orbassano , 10043, Italy
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Perugia , 06132, Italy
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Pisa , 56124, 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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Chuo-ku , 104-0, Japan
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Habikino-shi , 583-8, Japan
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Hidaka-shi , 350-1, Japan
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Hirakata-shi , 573-1, Japan
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Kashiwa , 277-8, Japan
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Kitaadachi-gun , 362-0, Japan
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Kobe-shi , 650-0, 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 , 460-0, Japan
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Natori-shi , 981-1, Japan
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Osaka-shi , 534-0, Japan
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Osaka-shi , 541-8, Japan
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Osakasayama , 589-8, Japan
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Sakai-shi , 591-8, Japan
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Sendai-shi , 980-0, Japan
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Shinjuku-ku , 160-0, Japan
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Sunto-gun , 411-8, Japan
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Ube-shi , 755-0, Japan
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Yokohama-shi , 236-0, Japan
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Yokohama-shi , 241-8, Japan
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Goyang-si , 10408, Korea, Republic of
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Hwasun-gun , 58128, 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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Seoul , 06351, Korea, Republic of
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Seoul , 152-7, Korea, Republic of
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Cebu City , 6000, Philippines
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Quezon City , 0870, Philippines
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Quezon City , 1100, Philippines
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Quezon City , 1101, Philippines
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Gdańsk , 80-95, Poland
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Warszawa , 02-78, Poland
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Singapore , 11922, Singapore
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Singapore , 16961, Singapore
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Singapore , 30844, Singapore
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Barcelona , 08908, Spain
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Gerona , 17007, Spain
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Madrid , 28007, Spain
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Madrid , 28050, Spain
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Málaga , 29010, Spain
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Sevilla , 41009, Spain
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Sevilla , 41013, Spain
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Valencia , 46026, Spain
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Taichung , 40447, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 704, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 112, Taiwan
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Hat Yai , 90110, Thailand
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Muang , 50200, Thailand
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London , EC1A , United Kingdom
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Manchester , M20 4, United Kingdom
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Stoke-on-Trent , ST4 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

446

Study ID:

NCT02087423

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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