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
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
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)
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There are 136 Locations for this study
Goodyear Arizona, , United States
Santa Rosa California, 95403, United States
New Haven Connecticut, 06511, United States
Port Saint Lucie Florida, 34952, United States
Tampa Florida, 33612, United States
Lawrenceville Georgia, 30046, United States
Waterloo Iowa, 50701, United States
Topeka Kansas, 66606, United States
Bethesda Maryland, 20817, United States
Burlington Massachusetts, 01803, United States
Worcester Massachusetts, 01608, United States
Saint Louis Park Minnesota, 55426, United States
Bronx New York, 10461, United States
New York New York, 10011, United States
New York New York, 10016, United States
New York New York, 10032, United States
New York New York, 10065, United States
Huntersville North Carolina, 28078, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58102, United States
Blue Ash Ohio, 45242, United States
Canton Ohio, 44718, United States
Middletown Ohio, 45042, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Spokane Washington, 99208, United States
Wenatchee Washington, 98801, United States
Wien , 1145, Austria
Brussel , 1000, Belgium
Gent , 9000, Belgium
Gilly , 6060, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Regina Saskatchewan, S4T 7, Canada
Brno , 656 5, Czechia
Praha 5 , 150 0, Czechia
Praha 8 , 180 8, Czechia
Praha , 14059, Czechia
Bordeaux Cedex , 33076, France
Brest Cedex , 29609, France
Creteil , 94010, France
Dijon , 21034, France
Le Mans Cedex 02 , 72015, France
Marseille , 13015, France
Pessac , 33600, France
Rennes Cedex 09 , 35033, France
Saint Herblain Cedex , 44805, France
Toulouse Cedex 9 , 31059, France
Berlin , 10967, Germany
Berlin , , Germany
Borstel , 23845, Germany
Dortmund , 44263, Germany
Frankfurt am Main , 60590, Germany
Freiburg , 79106, Germany
Großhansdorf , 22927, Germany
Hamburg , 20251, Germany
Heidelberg , 69126, Germany
Köln , 50924, Germany
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Győr , 9024, Hungary
Szolnok , 5000, Hungary
Tatabánya , 2800, Hungary
Törökbálint , 2045, Hungary
Candiolo , 10060, Italy
Catania , 95125, Italy
Milano , 20133, Italy
Monza , 20900, Italy
Orbassano , 10043, Italy
Perugia , 06132, Italy
Pisa , 56124, Italy
Roma , 00144, Italy
Rozzano , 20089, Italy
Akashi-shi , 673-8, Japan
Bunkyo-ku , 113-8, Japan
Chuo-ku , 104-0, Japan
Habikino-shi , 583-8, Japan
Hidaka-shi , 350-1, Japan
Hirakata-shi , 573-1, Japan
Kashiwa , 277-8, Japan
Kitaadachi-gun , 362-0, Japan
Kobe-shi , 650-0, Japan
Koto-ku , 135-8, Japan
Kurume-shi , 830-0, Japan
Nagoya-shi , 460-0, Japan
Natori-shi , 981-1, Japan
Osaka-shi , 534-0, Japan
Osaka-shi , 541-8, Japan
Osakasayama , 589-8, Japan
Sakai-shi , 591-8, Japan
Sendai-shi , 980-0, Japan
Shinjuku-ku , 160-0, Japan
Sunto-gun , 411-8, Japan
Ube-shi , 755-0, Japan
Yokohama-shi , 236-0, Japan
Yokohama-shi , 241-8, Japan
Goyang-si , 410-7, Korea, Republic of
Hwasun-gun , 58128, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 152-7, Korea, Republic of
Cebu City , 6000, Philippines
Quezon City , 0870, Philippines
Quezon City , 1100, Philippines
Quezon City , 1101, Philippines
Gdańsk , 80-95, Poland
Warszawa , 02-78, Poland
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Singapore , 30844, Singapore
Barcelona , 08908, Spain
Gerona , 17007, Spain
Madrid , 28007, Spain
Madrid , 28050, Spain
Málaga , 29010, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Hat Yai , 90110, Thailand
Muang , 50200, Thailand
London , EC1A , United Kingdom
Manchester , M20 4, United Kingdom
Stoke-on-Trent , ST4 6, United Kingdom
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