Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Launched by ASTRAZENECA · May 22, 2015
Trial Information
Current as of May 22, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness and safety of a new treatment for patients with advanced non-small-cell lung cancer (NSCLC). Specifically, the study is looking at a combination of two drugs, MEDI4736 and tremelimumab, compared to the standard chemotherapy treatment. The goal is to see if this new treatment can help patients who have not received any previous chemotherapy for their cancer.
To participate in the trial, patients need to be at least 18 years old, have Stage IV NSCLC, and not have certain genetic mutations that could affect treatment. They should also have a good performance status, which means they are well enough to handle the treatment. During the trial, participants will receive either the new combination therapy or the standard chemotherapy, and their progress will be closely monitored by the research team. It's important to note that this trial is currently active but not recruiting new participants.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- For inclusion in the study, patients should fulfill the following criteria:
- • Aged at least 18 years
- • Documented evidence of Stage IV NSCLC
- • No sensitizing EGFR mutation or ALK rearrangement
- • No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
- • World Health Organization (WHO) Performance Status of 0 or 1
- Exclusion Criteria:
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- • 1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
- • 2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
- • 3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
- • 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\]
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Athens, Georgia, United States
Honolulu, Hawaii, United States
Mineola, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Barcelona, , Spain
Omaha, Nebraska, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Tampa, Florida, United States
Pembroke Pines, Florida, United States
Omsk, , Russian Federation
St. Petersburg, , Russian Federation
Brussels, , Belgium
Liège, , Belgium
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
A Coruña, , Spain
Scottsdale, Arizona, United States
Summit, New Jersey, United States
Milano, , Italy
Bakersfield, California, United States
Fullerton, California, United States
Santa Maria, California, United States
Leuven, , Belgium
Toronto, Ontario, Canada
Lille, , France
Siena, , Italy
Sacramento, California, United States
Charleroi, , Belgium
Kingston, Ontario, Canada
Breda, , Netherlands
Rotterdam, , Netherlands
Málaga, , Spain
Oshawa, Ontario, Canada
Los Angeles, California, United States
Redondo Beach, California, United States
Saint Louis, Missouri, United States
Mainz, , Germany
Arnhem, , Netherlands
Groningen, , Netherlands
Saint Petersburg, , Russian Federation
Richmond, Virginia, United States
Bad Berka, , Germany
Hemer, , Germany
Tucson, Arizona, United States
Freiburg, , Germany
Münster, , Germany
Oldenburg, , Germany
Ulm, , Germany
Würzburg, , Germany
West Hollywood, California, United States
Melbourne, , Australia
Amsterdam, , Netherlands
Jacksonville, Florida, United States
La Jolla, California, United States
Deszk, , Hungary
Taichung, , Taiwan
Taipei, , Taiwan
Tao Yuan, , Taiwan
Chiang Mai, , Thailand
Heidelberg, , Germany
Löwenstein, , Germany
Budapest, , Hungary
Kecskemét, , Hungary
Lyon Cedex 08, , France
Obninsk, , Russian Federation
Bellinzona, , Switzerland
Box Hill, , Australia
Sevilla, , Spain
Baltimore, Maryland, United States
Brest Cedex, , France
Genova, , Italy
Aachen, , Germany
Sudbury, Ontario, Canada
Majadahonda, , Spain
Valencia, , Spain
Mitaka Shi, , Japan
Suwon Si, , Korea, Republic Of
Bangkok, , Thailand
Lausanne, , Switzerland
Kaposvár, , Hungary
Pécs, , Hungary
Marseille Cedex, , France
Newmarket, Ontario, Canada
Creteil, , France
New Haven, Connecticut, United States
Berlin, , Germany
Duffel, , Belgium
Osakasayama, , Japan
Sakai Shi, , Japan
Madison, Wisconsin, United States
Jinju Si, , Korea, Republic Of
Seongnam Si, , Korea, Republic Of
Gauting, , Germany
Miskolc, , Hungary
Busan, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
San Giovanni Rotondo, , Italy
Kyoto Shi, , Japan
Shinjuku Ku, , Japan
Alicante, , Spain
Ho Chi Minh, , Vietnam
Edelény, , Hungary
Den Bosch, , Netherlands
Maastricht, , Netherlands
Kogarah, , Australia
Hirakata Shi, , Japan
Kanazawa, , Japan
Kobe Shi, , Japan
Gosford, , Australia
Lubeck, , Germany
Meldola, , Italy
Daegu, , Korea, Republic Of
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
Osaka Shi, , Japan
Gerona, , Spain
Iwakuni Shi, , Japan
Koga Shi, , Japan
Changwon Si, , Korea, Republic Of
Hat Yai, , Thailand
Incheon, , Korea, Republic Of
Bordeaux Cedex, , France
Goyang Si, , Korea, Republic Of
Jaén, , Spain
Tainan City, , Taiwan
Hamburg, , Germany
Nagoya Shi, , Japan
Sendai Shi, , Japan
Ube Shi, , Japan
Southport, , Australia
Ulsan, , Korea, Republic Of
Port Macquarie, , Australia
Madrid, , Spain
Hirosaki Shi, , Japan
Kishiwada Shi, , Japan
Kaohsiung, , Taiwan
Seoul, , Korea, Republic Of
Yokohama Shi, , Japan
Khon Kaen, , Thailand
San Luis Obispo, California, United States
Daejeon, , Korea, Republic Of
St Leonards, , Australia
Velbert, , Germany
Fukushima Shi, , Japan
Yuma, Arizona, United States
Nagaoka Shi, , Japan
Minneapolis, Minnesota, United States
North Charleston, South Carolina, United States
Sault Ste. Marie, Ontario, Canada
St. Catharines, Ontario, Canada
Homburg/Saar, , Germany
Immenhausen, , Germany
Himeji Shi, , Japan
Iizuka Shi, , Japan
Izumi Shi, , Japan
Okayama Shi, , Japan
Saga Shi, , Japan
Saitama Shi, , Japan
Tokushima Shi, , Japan
Yokosuka Shi, , Japan
León, , Spain
Hanoi City, , Vietnam
Patients applied
Trial Officials
Stuart McIntosh, MD
Study Director
AstraZeneca, Alderley Park, Cheshire, UK
Naiyer Rizvi, MD
Principal Investigator
Columbia University Medical Center, New York, NY, USA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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