A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
NCT ID: NCT02352948
Last Updated: 2024-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
597 participants
INTERVENTIONAL
2015-01-13
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEDI4736 (durvalumab) monotherapy in Sub-study A
MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.
MEDI4736 (durvalumab)
MEDI4736 (durvalumab) treatment by intravenous infusion
Standard of Care in Sub-study A
Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.
Vinorelbine
Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
Gemcitabine
Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
Erlotinib
Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
MEDI4736 (durvalumab) + tremelimumab in Sub-study B
MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)
MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
Standard of Care in Sub-study B
Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.
Vinorelbine
Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
Gemcitabine
Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
Erlotinib
Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
MEDI4736 (durvalumab) monotherapy in Sub-study B
MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
MEDI4736 (durvalumab)
MEDI4736 (durvalumab) treatment by intravenous infusion
tremelimumab in Sub-study B
tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
tremelimumab (anti-CTLA4)
tremelimumab (anti-CTLA4) treatment by intravenous infusion
Interventions
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MEDI4736 (durvalumab)
MEDI4736 (durvalumab) treatment by intravenous infusion
Vinorelbine
Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
Gemcitabine
Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
Erlotinib
Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)
MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
tremelimumab (anti-CTLA4)
tremelimumab (anti-CTLA4) treatment by intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Documented evidence of NSCLC (Stage IIIB/ IV disease)
* Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
* Estimated life expectancy more than 12 weeks
Exclusion Criteria
* Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
* Active or prior documented autoimmune disease within the past 2 years
* Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
* Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) \>Grade 2 from previous anti-cancer therapy
* Known EGFR TK activating mutations or ALK rearrangements
* 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)
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Stockman, MBChB, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Chandler, Arizona, United States
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Anaheim, California, United States
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Duarte, California, United States
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La Jolla, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Fort Myers, Florida, United States
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Orlando, Florida, United States
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Port Saint Lucie, Florida, United States
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St. Petersburg, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Lawrenceville, Georgia, United States
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Chicago, Illinois, United States
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Waterloo, Iowa, United States
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Ashland, Kentucky, United States
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Rockville, Maryland, United States
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Battle Creek, Michigan, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Pinehurst, North Carolina, United States
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Cincinnati, Ohio, United States
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West Chester, Ohio, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Salt Lake City, Utah, United States
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Spokane, Washington, United States
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Murdoch, , Australia
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Port Macquarie, , Australia
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Charleroi, , Belgium
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Ghent, , Belgium
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Libramont-Chevigny, , Belgium
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Mons, , Belgium
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Roeselare, , Belgium
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Yvoir, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Nová Ves pod Pleší, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Avignon, , France
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Bayonne, , France
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Brest, , France
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Créteil, , France
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Le Mans, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Pau, , France
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Saint-Herblain, , France
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Toulon, , France
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Villejuif, , France
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Gauting, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Homburg, , Germany
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Löwenstein, , Germany
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Regensburg, , Germany
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Trier, , Germany
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Ulm, , Germany
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Villingen-Schwenningen, , Germany
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Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Miskolc, , Hungary
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Törökbálint, , Hungary
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Zalaegerszeg, , Hungary
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Zalaegerszeg, , Hungary
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Tel Litwinsky, , Israel
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Aviano, , Italy
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Candiolo, , Italy
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Catania, , Italy
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Cremona, , Italy
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Genova, , Italy
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Lucca, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Monza, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Pisa, , Italy
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Rimini, , Italy
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Terni, , Italy
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Fukuoka, , Japan
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Habikino-shi, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Hirosaki-shi, , Japan
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Hiroshima, , Japan
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Kanazawa, , Japan
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Kobe, , Japan
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Kurume-shi, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Natori-shi, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sayama, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Takatsuki-shi, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Amsterdam, , Netherlands
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Alba Iulia, , Romania
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Baia Mare, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Onești, , Romania
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Oradea, , Romania
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Timișoara, , Romania
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Arkhangelsk, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Belgrade, , Serbia
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Gornji Matejevac, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Busan, , South Korea
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Cheongju-si, , South Korea
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Incheon, , South Korea
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Jeonnam, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Girona, , Spain
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Jaén, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Muang, , Thailand
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Phitsanulok, , Thailand
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Songkhla, , Thailand
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Birmingham, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Southampton, , United Kingdom
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Stevenage, , United Kingdom
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Truro, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Martin ML, Correll J, Walding A, Ryden A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2022 Jan;31(1):135-146. doi: 10.1007/s11136-021-02882-6. Epub 2021 May 31.
Planchard D, Reinmuth N, Orlov S, Fischer JR, Sugawara S, Mandziuk S, Marquez-Medina D, Novello S, Takeda Y, Soo R, Park K, McCleod M, Geater SL, Powell M, May R, Scheuring U, Stockman P, Kowalski D. ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer. Ann Oncol. 2020 May;31(5):609-618. doi: 10.1016/j.annonc.2020.02.006. Epub 2020 Feb 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AstraZeneca Cancer Study Locator Service [email protected] Phone number: 1-877-400-465
Other Identifiers
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2014-000338-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4191C00004
Identifier Type: -
Identifier Source: org_study_id
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