Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
NCT ID: NCT03703297
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
730 participants
INTERVENTIONAL
2018-09-27
2026-10-23
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
TRIPLE
Study Groups
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Durvalumab + Placebo
Durvalumab monotherapy: Durvalumab (1500 mg intravenous \[IV\]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
Durvalumab
Durvalumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Durvalumab + Tremelimumab
Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.
Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Placebo + Placebo
Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.
Placebo
Placebo IV (intravenous infusion)
Interventions
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Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.
Exclusion Criteria
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
4. Active infection including tuberculosis, HIV, hepatitis B and C
5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
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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Haiyi Jiang, M.D.
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Tucson, Arizona, United States
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Santa Rosa, California, United States
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New Haven, Connecticut, United States
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Fort Myers, Florida, United States
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Orange City, Florida, United States
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St. Petersburg, Florida, United States
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Marietta, Georgia, United States
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Hines, Illinois, United States
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Fort Wayne, Indiana, United States
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Muncie, Indiana, United States
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Lexington, Kentucky, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Summit, New Jersey, United States
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New Hyde Park, New York, United States
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Chapel Hill, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Kennewick, Washington, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, United States
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Huntington, West Virginia, United States
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Milwaukee, Wisconsin, United States
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Rosario, , Argentina
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Aalst, , Belgium
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Anderlecht, , Belgium
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Brussels, , Belgium
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Hasselt, , Belgium
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Roeselare, , Belgium
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Edmonton, Alberta, Canada
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Toronto, CA, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Chongqing, , China
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Fuzhou, , China
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Hangzhou, , China
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Hefei, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Yangzhou, , China
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Zhengzhou, , China
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Brno, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Berlin, , Germany
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Cologne, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Heidelberg, , Germany
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Mainz, , Germany
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Münster, , Germany
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Oldenburg, , Germany
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Regensburg, , Germany
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Stuttgart, , Germany
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Würzburg, , Germany
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Bengaluru, , India
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Gurgaon, , India
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Brescia, , Italy
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Milan, , Italy
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Milan, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Terni, , Italy
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Iwakuni-shi, , Japan
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Kashiwa, , Japan
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Kōtoku, , Japan
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Kurume-shi, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sayama, , Japan
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Sendai, , Japan
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Sunto-gun, , Japan
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Tokushima, , Japan
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Ube-shi, , Japan
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Harderwijk, , Netherlands
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Hengelo, , Netherlands
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Gdansk, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Tomaszów Mazowiecki, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Kazan', , Russia
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Kirov, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Omsk, , Russia
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Ufa, , Russia
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Volgograd, , Russia
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Changwon-si, , South Korea
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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Jinju, , 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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Suwon, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Yunlin, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Manchester, , United Kingdom
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Truro, , United Kingdom
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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Zenke Y, Shiraishi Y, Goto Y, Azuma K, Okishio K, Ogino H, Horio Y, Oizumi S, Hayama M, Nii M, Harada M, Mann H, Olivo YS, Jiang H, Senan S. Durvalumab Post Concurrent Chemoradiotherapy in Japanese Patients With Limited-Stage Small-Cell Lung Cancer in the Phase 3 ADRIATIC Trial. Cancer Sci. 2025 Sep 21. doi: 10.1111/cas.70188. Online ahead of print.
Cheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, Zenke Y, Lee KH, Wang Q, Navarro A, Bernabe R, Buchmeier EL, Chang JW, Shiraishi Y, Sezgin Goksu S, Badzio A, Shi A, Daniel DB, Hoa NTT, Zemanova M, Mann H, Gowda H, Jiang H, Senan S; ADRIATIC Investigators. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327. doi: 10.1056/NEJMoa2404873. Epub 2024 Sep 13.
Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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d933qc00001-csp-v5\_for redaction\_Redacted
Other Identifiers
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2018-000867-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933QC00001
Identifier Type: -
Identifier Source: org_study_id
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