A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

ClinicalTrials.gov processed this data on May 9, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified May 2024 by AstraZeneca

Sponsor

AstraZeneca

Information Provided by (Responsible Party)

AstraZeneca

Clinicaltrials.gov Identifier

NCT03703297
Other Study ID Numbers: D933QC00001
First Submitted: September 19, 2018
First Posted: October 11, 2018
Last Update Posted: May 10, 2024
Last Verified: May 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Small Cell Lung Cancer
  • Drug: Durvalumab
  • Drug: Tremelimumab
  • Other: Placebo

Study Design

Study TypeInterventional
Actual Enrollment730 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
Study Start DateSeptember 27, 2018
Anticipated Primary Completion DateSeptember 5, 2024
Anticipated Study Completion DateSeptember 5, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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.
  • Drug: Durvalumab
    • Durvalumab IV (intravenous infusion)
  • Other: Placebo
    • 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.
    • Drug: Durvalumab
      • Durvalumab IV (intravenous infusion)
    • Drug: Tremelimumab
      • 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.
      • Other: Placebo

        Outcome Measures

        Primary Outcome Measures

        1. Progression-free survival (PFS) [Approximately 6 years]
          To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of PFS
        2. Overall Survival (OS) [Approximately 6 years]
          To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of OS

        Secondary Outcome Measures

        1. Overall Survival (OS) [Approximately 6 years]
          To assess the efficacy of Durvalumab & Tremelimumab combination therapy vs Placebo in terms of OS
        2. Objective Response Rate (ORR) [Approximately 6 years]
        3. Progression-free survival PFS [Approximately 6 years]
          To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS
        4. Progression-free survival at 18 months (PFS18) [Approximately 6 years]
        5. Progression-free survival at 24 months (PFS24) [Approximately 6 years]
        6. Time to death or distant metastasis (TTDM) [Approximately 6 years]
        7. Proportion of patients alive at 24 months (OS24) [Approximately 6 years]
        8. Proportion of patients alive at and 36 months (OS36) [Approximately 6 years]
        9. Time from randomization to second progression (PFS2) [Approximately 6 years]
        10. To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3 [Approximately 6 years]
        11. To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration) [Approximately 6 years]
        12. Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative) [Approximately 6 years]
        13. PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR). [Approximately 6 years]
          To investigate the relationship between PDL1 expression & spatial distribution with Durva (mono) therapy & Durva+Treme (combination) therapy
        14. To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13 [Approximately 6 years]

        Eligibility Criteria

        Ages Eligible for Study 18 Years to 130 Years (Adult, Older Adult)
        Sexes Eligible for Study All
        Accepts Healthy Volunteers No
        Inclusion Criteria
        • Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
        • 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.
        • 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
        • Extensive-stage SCLC
        • Active or prior documented autoimmune or inflammatory disorders
        • Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
        • Active infection including tuberculosis, HIV, hepatitis B and C
        • Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

        Contacts and Locations

        Sponsors and Collaborators AstraZeneca
        Locations
        • Research Site | Tucson, Arizona, United States, 85715
        • Research Site | Santa Rosa, California, United States, 95403
        • Research Site | New Haven, Connecticut, United States, 06510
        • Research Site | Fort Myers, Florida, United States, 33901
        • Research Site | Orange City, Florida, United States, 32763
        • Research Site | Saint Petersburg, Florida, United States, 33705
        • Research Site | Marietta, Georgia, United States, 30060
        • Research Site | Hines, Illinois, United States, 60141
        • Research Site | Fort Wayne, Indiana, United States, 46804
        • Research Site | Muncie, Indiana, United States, 47303
        • Research Site | Lexington, Kentucky, United States, 40536
        • Research Site | Annapolis, Maryland, United States, 21401
        • Research Site | Baltimore, Maryland, United States, 21287
        • Research Site | Towson, Maryland, United States, 21204
        • Research Site | Boston, Massachusetts, United States, 02114
        • Research Site | Detroit, Michigan, United States, 48201
        • Research Site | Grand Rapids, Michigan, United States, 49503
        • Research Site | Minneapolis, Minnesota, United States, 55407
        • Research Site | Summit, New Jersey, United States, 07902
        • Research Site | New Hyde Park, New York, United States, 11042
        • Research Site | Chapel Hill, North Carolina, United States, 27599
        • Research Site | Portland, Oregon, United States, 97239
        • Research Site | Philadelphia, Pennsylvania, United States, 19111
        • Research Site | Pittsburgh, Pennsylvania, United States, 15212
        • Research Site | Sioux Falls, South Dakota, United States, 57104
        • Research Site | Chattanooga, Tennessee, United States, 37404
        • Research Site | Nashville, Tennessee, United States, 37203
        • Research Site | Nashville, Tennessee, United States, 37232
        • Research Site | Dallas, Texas, United States, 75390
        • Research Site | Kennewick, Washington, United States, 99336
        • Research Site | Tacoma, Washington, United States, 98405
        • Research Site | Charleston, West Virginia, United States, 25304
        • Research Site | Huntington, West Virginia, United States, 25701
        • Research Site | Milwaukee, Wisconsin, United States, 53226
        • Research Site | Caba, Argentina, C1012AAR
        • Research Site | Caba, Argentina, C1280AEB
        • Research Site | Córdoba, Argentina, X5004BAL
        • Research Site | Mar del Plata, Argentina, 7600
        • Research Site | Rosario, Argentina, 2000
        • Research Site | Aalst, Belgium, 9300
        • Research Site | Anderlecht, Belgium, 1070
        • Research Site | Bruxelles, Belgium, 1200
        • Research Site | Hasselt, Belgium, 3500
        • Research Site | Roeselare, Belgium, 8800
        • Research Site | Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site | Toronto, CA, Canada, M5G 2M9
        • Research Site | Winnipeg, Manitoba, Canada, R3E 0V9
        • Research Site | Hamilton, Ontario, Canada, L8V 5C2
        • Research Site | London, Ontario, Canada, N6A 5W9
        • Research Site | Ottawa, Ontario, Canada, K1H 8L6
        • Research Site | Toronto, Ontario, Canada, M4N 3M5
        • Research Site | Montreal, Quebec, Canada, H4A 3J1
        • Research Site | Beijing, China, 100021
        • Research Site | Beijing, China, 100036
        • Research Site | Beijing, China, 100142
        • Research Site | Beijing, China, 100191
        • Research Site | Beijing, China, 100730
        • Research Site | Bengbu, China, 233060
        • Research Site | Changchun, China, 130000
        • Research Site | Changsha, China, 410013
        • Research Site | Chengdu, China, 610042
        • Research Site | Chongqing, China, 400030
        • Research Site | Chongqing, China, 400042
        • Research Site | Fuzhou, China, 350011
        • Research Site | Hangzhou, China, 310003
        • Research Site | Hefei, China, 230601
        • Research Site | Shanghai, China, 200030
        • Research Site | Shanghai, China, 200032
        • Research Site | Shenyang, China, 110001
        • Research Site | Shenyang, China, 110042
        • Research Site | Tianjin, China, 300060
        • Research Site | Wuhan, China, 430010
        • Research Site | Wuhan, China, 430022
        • Research Site | Wuhan, China, 430030
        • Research Site | Yangzhou, China, 225001
        • Research Site | Zhengzhou, China, 450008
        • Research Site | Brno, Czechia, 639 00
        • Research Site | Olomouc, Czechia, 77900
        • Research Site | Ostrava, Czechia, 703 00
        • Research Site | Praha 2, Czechia, 128 08
        • Research Site | Praha, Czechia, 140 59
        • Research Site | Berlin, Germany, 12351
        • Research Site | Freiburg, Germany, 79106
        • Research Site | Gauting, Germany, 82131
        • Research Site | Gerlingen, Germany, 70839
        • Research Site | Heidelberg, Germany, 69126
        • Research Site | Köln, Germany, 51109
        • Research Site | Mainz, Germany, 55131
        • Research Site | Münster, Germany, 48149
        • Research Site | Oldenburg, Germany, 26121
        • Research Site | Regensburg, Germany, 93053
        • Research Site | Wuerzburg, Germany, 97080
        • Research Site | Bengaluru, India, 560076
        • Research Site | Gurgaon, India, 122001
        • Research Site | Brescia, Italy, 25123
        • Research Site | Milano, Italy, 20133
        • Research Site | Milano, Italy, 20141
        • Research Site | Orbassano, Italy, 10043
        • Research Site | Parma, Italy, 43126
        • Research Site | Roma, Italy, 00100
        • Research Site | Rozzano, Italy, 20089
        • Research Site | Terni, Italy, 05100
        • Research Site | Bunkyo-ku, Japan, 160-0023
        • Research Site | Chuo-ku, Japan, 104-0045
        • Research Site | Fukuoka-shi, Japan, 812-8582
        • Research Site | Iwakuni-shi, Japan, 740-8510
        • Research Site | Kashiwa, Japan, 277-8577
        • Research Site | Koto-ku, Japan, 135-8550
        • Research Site | Kurume-shi, Japan, 830-0011
        • Research Site | Nagoya-shi, Japan, 464-8681
        • Research Site | Nagoya-shi, Japan, 466-8560
        • Research Site | Niigata-shi, Japan, 951-8566
        • Research Site | Osakasayama, Japan, 589-8511
        • Research Site | Sakai-shi, Japan, 591-8555
        • Research Site | Sapporo-shi, Japan, 003-0804
        • Research Site | Sendai-shi, Japan, 980-0873
        • Research Site | Sunto-gun, Japan, 411-8777
        • Research Site | Tokushima-shi, Japan, 770-8503
        • Research Site | Ube-shi, Japan, 755-0241
        • Research Site | Changwon-si, Korea, Republic of, 51353
        • Research Site | Cheongju-si, Korea, Republic of, 28644
        • Research Site | Daegu, Korea, Republic of, 42415
        • Research Site | Goyang-si, Korea, Republic of, 10408
        • Research Site | Jinju-si, Korea, Republic of, 52727
        • Research Site | Seongnam-si, Korea, Republic of, 13620
        • Research Site | Seoul, Korea, Republic of, 03080
        • Research Site | Seoul, Korea, Republic of, 03722
        • Research Site | Seoul, Korea, Republic of, 05505
        • Research Site | Suwon-si, Korea, Republic of, 16499
        • Research Site | Amsterdam, Netherlands, 1081 HV
        • Research Site | Den Bosch, Netherlands, 5223 GZ
        • Research Site | Groningen, Netherlands, 9713 GZ
        • Research Site | Harderwijk, Netherlands, 3844 DG
        • Research Site | Hengelo, Netherlands, 7555 DL
        • Research Site | Gdańsk, Poland, 80-214
        • Research Site | Olsztyn, Poland, 10-357
        • Research Site | Poznań, Poland, 60-569
        • Research Site | Tomaszów Mazowiecki, Poland, 97-200
        • Research Site | Warszawa, Poland, 02-781
        • Research Site | Wroclaw, Poland, 53-413
        • Research Site | Kazan, Russian Federation, 420029
        • Research Site | Kirov, Russian Federation, 610021
        • Research Site | Moscow, Russian Federation, 105229
        • Research Site | Moscow, Russian Federation, 115478
        • Research Site | Moscow, Russian Federation, 125284
        • Research Site | Obninsk, Russian Federation, 249036
        • Research Site | Omsk, Russian Federation, 644013
        • Research Site | Ufa, Russian Federation, 450054
        • Research Site | Volgograd, Russian Federation, 400138
        • Research Site | Barcelona, Spain, 08003
        • Research Site | Barcelona, Spain, 08035
        • Research Site | Madrid, Spain, 28034
        • Research Site | Madrid, Spain, 28040
        • Research Site | Madrid, Spain, 28041
        • Research Site | Oviedo, Spain, 33011
        • Research Site | Sevilla, Spain, 41013
        • Research Site | Valencia, Spain, 46026
        • Research Site | Zaragoza, Spain, 50009
        • Research Site | Hsinchu, Taiwan, 300
        • Research Site | Kaohsiung City, Taiwan, 83301
        • Research Site | Keelung City, Taiwan, 20445
        • Research Site | Taichung, Taiwan, 40705
        • Research Site | Tainan City, Taiwan, 70403
        • Research Site | Tainan, Taiwan, 736
        • Research Site | Taipei, Taiwan, 112
        • Research Site | Taipei, Taiwan, 235
        • Research Site | Taoyuan City, Taiwan, 333
        • Research Site | Yunlin, Taiwan, 640
        • Research Site | Adana, Turkey, 01060
        • Research Site | Ankara, Turkey, 06230
        • Research Site | Ankara, Turkey, 06280
        • Research Site | Antalya, Turkey, 07059
        • Research Site | Edirne, Turkey, 22030
        • Research Site | Istanbul, Turkey, 34030
        • Research Site | Izmir, Turkey, 35620
        • Research Site | Konya, Turkey, 42080
        • Research Site | Samsun, Turkey,
        • Research Site | Manchester, United Kingdom, M20 4BX
        • Research Site | Truro, United Kingdom, TR1 3LJ
        • Research Site | Hanoi, Vietnam, 100000
        • Research Site | Ho Chi Minh, Vietnam, 700000
        • Research Site | Ho Chi Minh, Vietnam, 70000
        Investigators