Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
POSEIDON
A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)
2 other identifiers
interventional
1,186
19 countries
175
Brief Summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2017
Longer than P75 for phase_3
175 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 23, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2021
CompletedResults Posted
Study results publicly available
April 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2027
ExpectedMarch 13, 2026
February 1, 2026
3.8 years
May 22, 2017
March 11, 2022
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
PFS (per RECIST version 1.1 \[RECIST 1.1\] using Blinded Independent Central Review \[BICR\] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity).
Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
Overall Survival (OS); D + SoC Compared With SoC Alone
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity).
From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).
Secondary Outcomes (12)
PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC
Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months.
OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC
From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).
Objective Response Rate (ORR)
Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
Best Objective Response (BoR)
Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
Duration of Response (DoR)
Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
- +7 more secondary outcomes
Study Arms (3)
Treatment Arm 1
EXPERIMENTALdurvalumab + tremelimumab combination therapy + SoC chemotherapy
Treatment Arm 2
EXPERIMENTALdurvalumab monotherapy + SoC chemotherapy
Treatment Arm 3
ACTIVE COMPARATORSoC chemotherapy alone
Interventions
Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance \[i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)\] until objective disease progression.
Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance \[i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)\] until objective disease progression.
IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria
IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.
Standard of care chemotherapy (squamous and non-squamous patients): Abraxane 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Carboplatin Area under the plasma drug concentration-time curve (AUC) 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).
Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).
Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).
Eligibility Criteria
You may qualify if:
- Aged at least 18 years.
- Histologically or cytologically documented Stage IV NSCLC.
- Confirmed tumor PD-L1 status prior to randomization.
- Patients must have tumors that lack activating EGFR mutations and ALK fusions.
- No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.
You may not qualify if:
- Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
- Active or prior documented autoimmune or inflammatory disorders.
- Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (175)
Research Site
Phoenix, Arizona, 85054, United States
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Bakersfield, California, 93309, United States
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Santa Monica, California, 90404, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32224, United States
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St. Petersburg, Florida, 33705, United States
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West Palm Beach, Florida, 33401, United States
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Louisville, Kentucky, 40202, United States
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Kansas City, Missouri, 64132, United States
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Canton, Ohio, 44710, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77090, United States
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Richmond, Virginia, 23298, United States
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30380-472, Brazil
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Curitiba, 81520-060, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Ribeirão Preto, 14015-140, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Santo André, 09060-650, Brazil
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Santo André, 09080-110, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01209-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 03102-002, Brazil
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1330, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9010, Bulgaria
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Beijing, 100021, China
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Beijing, 100142, China
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Changchun, 130012, China
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Changsha, 410013, China
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Fuzhou, 350014, China
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Guangzhou, 510080, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230601, China
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Kunming, CN-650034, China
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Linyi, 276000, China
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Liuchow, 545006, China
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Nanjing, 210009, China
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Qingdao, 110016, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Shantou, 515041, China
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Wuhan, 430022, China
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Wuhan, 430079, China
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Xining, 810001, China
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Yangzhou, 225001, China
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Zhanjiang, 524001, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Berlin, 13125, Germany
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Essen, 45122, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Hamburg, 20251, Germany
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Hamburg, 21075, Germany
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Heidelberg, 69126, Germany
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Immenhausen, 34376, Germany
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Mainz, 55131, Germany
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Oldenburg, 26121, Germany
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Würzburg, 97067, Germany
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Shatin, 00000, Hong Kong
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Kecskemét, 6000, Hungary
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Miskolc, 3529, Hungary
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Törökbálint, 2045, Hungary
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hiroshima, 730-0011, Japan
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Iwakuni-shi, 740-8510, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 790-0007, Japan
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Okayama, 700-8558, Japan
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Okayama, 700-8607, Japan
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Sapporo, 003-0804, Japan
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Sayama, 589-8511, Japan
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Sunto-gun, 411-8777, Japan
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Toyoake-shi, 470-1101, Japan
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Ube-shi, 755-0241, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 241-8515, Japan
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Aguascalientes, 20230, Mexico
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Cuautitlán Izcalli, 54769, Mexico
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Guadalajara, 44280, Mexico
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Mexico City, 0 3100, Mexico
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México, 04739, Mexico
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México, 14080, Mexico
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Monterrey, 64060, Mexico
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Monterrey, 64460, Mexico
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Tuxtla Gutiérrez, 29030, Mexico
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Arequipa, AREQUIPA01, Peru
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Lima, L27, Peru
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Lima, LIMA 29, Peru
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Lima, LIMA 34, Peru
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Lima, LIMA 41, Peru
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San Isidro, 27, Peru
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Olsztyn, 10-357, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 02-781, Poland
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Wodzisław Śląski, 44-300, Poland
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Moscow, 105229, Russia
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Moscow, 115280, Russia
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Moscow, 115478, Russia
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Moscow, 125367, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 196603, Russia
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Saint Petersburg, 197758, Russia
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Cape Town, 7570, South Africa
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Durban, 4091, South Africa
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Johannesburg, 0001, South Africa
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Parktown, 2193, South Africa
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Pretoria, 0001, South Africa
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Rondebosch, 7700, South Africa
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Vereeniging, 1930, South Africa
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Busan, 47392, South Korea
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Chungcheongbuk-do, 28644, South Korea
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Daegu, 42415, South Korea
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Incheon, 21565, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 120-752, South Korea
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Seoul, 6351, South Korea
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Ulsan, 44033, South Korea
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Changhua, 50006, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taipei, 235, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Muang, 50200, Thailand
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Songkhla, 90110, Thailand
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Dnipro, 49102, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kirovohrad, 25006, Ukraine
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Kyiv, 03022, Ukraine
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Kyiv, 03115, Ukraine
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Lviv, 79031, Ukraine
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Odesa, 65055, Ukraine
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Sumy, 40022, Ukraine
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Vinnytsia, 21029, Ukraine
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Zaporizhzhia, 69040, Ukraine
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Leicester, LE1 5WW, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, NW1 2PG, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Related Publications (2)
He JZ, Duval V, Jauslin P, Goncalves A, Abegesah A, Fan C, Lim K, Song X, Chen C, Shi X, Mann H, Krug L, Ren S, Phipps A, Gibbs M, Zhou D. Population Pharmacokinetics and Exposure-Response Analysis for the CTLA-4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study. Clin Pharmacol Ther. 2023 Dec;114(6):1375-1386. doi: 10.1002/cpt.3063. Epub 2023 Oct 17.
PMID: 37777827DERIVEDJohnson ML, Cho BC, Luft A, Alatorre-Alexander J, Geater SL, Laktionov K, Kim SW, Ursol G, Hussein M, Lim FL, Yang CT, Araujo LH, Saito H, Reinmuth N, Shi X, Poole L, Peters S, Garon EB, Mok T; POSEIDON investigators. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study. J Clin Oncol. 2023 Feb 20;41(6):1213-1227. doi: 10.1200/JCO.22.00975. Epub 2022 Nov 3.
PMID: 36327426DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study also incorporates a China tail, comprising additional patients randomized after the end of the global cohort recruitment. Efficacy and safety of patients randomized in China will be reported at a later date once this separate analysis has been completed.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Xiaojin Shi, M.D., MSc
One MedImmune Way, Gaithersburg, Maryland 20878, United States
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2017
First Posted
May 23, 2017
Study Start
June 1, 2017
Primary Completion
March 12, 2021
Study Completion (Estimated)
November 15, 2027
Last Updated
March 13, 2026
Results First Posted
April 7, 2022
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.