Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Trial Title: Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

NCT ID: NCT03164616

Condition: Non Small Cell Lung Cancer NSCLC

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cisplatin
Carboplatin
Gemcitabine
Pemetrexed
Durvalumab
Albumin-Bound Paclitaxel
Tremelimumab

Conditions: Keywords:
NSCLC
Programmed cell death ligand 1 (PD-L1)
Durvalumab
Tremelimumab
Progression-free survival (PFS)
Overall survival (OS)

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Durvalumab
Description: IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria
Arm group label: Treatment Arm 1
Arm group label: Treatment Arm 2

Intervention type: Drug
Intervention name: Tremelimumab
Description: IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.
Arm group label: Treatment Arm 1

Intervention type: Drug
Intervention name: Abraxane + carboplatin
Description: 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).
Arm group label: Treatment Arm 1
Arm group label: Treatment Arm 2
Arm group label: Treatment Arm 3

Intervention type: Drug
Intervention name: Gemcitabine + cisplatin
Description: 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).
Arm group label: Treatment Arm 1
Arm group label: Treatment Arm 2
Arm group label: Treatment Arm 3

Intervention type: Drug
Intervention name: Gemcitabine + carboplatin
Description: 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).
Arm group label: Treatment Arm 1
Arm group label: Treatment Arm 2
Arm group label: Treatment Arm 3

Intervention type: Drug
Intervention name: Pemetrexed + carboplatin
Description: 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.
Arm group label: Treatment Arm 1
Arm group label: Treatment Arm 2
Arm group label: Treatment Arm 3

Intervention type: Drug
Intervention name: Pemetrexed + cisplatin
Description: 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.
Arm group label: Treatment Arm 1
Arm group label: Treatment Arm 2
Arm group label: Treatment Arm 3

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.

Detailed description: Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment. Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until objective disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An independent data monitoring committee (IDMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Criteria for eligibility:
Criteria:
Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Aged at least 18 years. 2. Histologically or cytologically documented Stage IV NSCLC. 3. Confirmed tumor PD-L1 status prior to randomization. 4. Patients must have tumors that lack activating EGFR mutations and ALK fusions. 5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC. 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines. 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. Active or prior documented autoimmune or inflammatory disorders. 3. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids. 4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Gender: All

Minimum age: 18 Years

Maximum age: 130 Years

Healthy volunteers: No

Locations:

Facility:
Name: Research Site

Address:
City: Phoenix
Zip: 85054
Country: United States

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Name: Research Site

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City: Bakersfield
Zip: 93309
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Zip: 37203
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Zip: 77090
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Address:
City: Richmond
Zip: 23298
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Address:
City: Barretos
Zip: 14784-400
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Address:
City: Belo Horizonte
Zip: 30380-472
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Address:
City: Curitiba
Zip: 81520-060
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Address:
City: Porto Alegre
Zip: 90035-003
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Name: Research Site

Address:
City: Porto Alegre
Zip: 90610-000
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Name: Research Site

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

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Name: Research Site

Address:
City: Ribeirao Preto
Zip: 14015-140
Country: Brazil

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Name: Research Site

Address:
City: Rio de Janeiro
Zip: 20231-050
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Facility:
Name: Research Site

Address:
City: Santo Andre
Zip: 09080-110
Country: Brazil

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Name: Research Site

Address:
City: Santo André
Zip: 09060-650
Country: Brazil

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Name: Research Site

Address:
City: Sao Paulo
Zip: 01209-000
Country: Brazil

Facility:
Name: Research Site

Address:
City: São José do Rio Preto
Zip: 15090-000
Country: Brazil

Facility:
Name: Research Site

Address:
City: São Paulo
Zip: 01246-000
Country: Brazil

Facility:
Name: Research Site

Address:
City: São Paulo
Zip: 03102-002
Country: Brazil

Facility:
Name: Research Site

Address:
City: Plovdiv
Zip: 4000
Country: Bulgaria

Facility:
Name: Research Site

Address:
City: Plovdiv
Zip: 4004
Country: Bulgaria

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Name: Research Site

Address:
City: Sofia
Zip: 1330
Country: Bulgaria

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Name: Research Site

Address:
City: Sofia
Zip: 1431
Country: Bulgaria

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Name: Research Site

Address:
City: Sofia
Zip: 1618
Country: Bulgaria

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Name: Research Site

Address:
City: Sofia
Zip: 1784
Country: Bulgaria

Facility:
Name: Research Site

Address:
City: Varna
Zip: 9010
Country: Bulgaria

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Name: Research Site

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Research Site

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Research Site

Address:
City: Changchun
Zip: 130012
Country: China

Facility:
Name: Research Site

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Research Site

Address:
City: Fuzhou
Zip: 350014
Country: China

Facility:
Name: Research Site

Address:
City: Guangzhou
Zip: 510080
Country: China

Facility:
Name: Research Site

Address:
City: Hangzhou
Zip: 310022
Country: China

Facility:
Name: Research Site

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Research Site

Address:
City: Hefei
Zip: 230601
Country: China

Facility:
Name: Research Site

Address:
City: Kunming
Zip: CN-650034
Country: China

Facility:
Name: Research Site

Address:
City: Linyi
Zip: 276000
Country: China

Facility:
Name: Research Site

Address:
City: Liuzhou
Zip: 545006
Country: China

Facility:
Name: Research Site

Address:
City: Nanjing
Zip: 210009
Country: China

Facility:
Name: Research Site

Address:
City: Qingdao
Zip: 110016
Country: China

Facility:
Name: Research Site

Address:
City: Shanghai
Zip: 200030
Country: China

Facility:
Name: Research Site

Address:
City: Shanghai
Zip: 200032
Country: China

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Name: Research Site

Address:
City: Shanghai
Zip: 200080
Country: China

Facility:
Name: Research Site

Address:
City: Shantou
Zip: 515041
Country: China

Facility:
Name: Research Site

Address:
City: Wuhan
Zip: 430022
Country: China

Facility:
Name: Research Site

Address:
City: Wuhan
Zip: 430079
Country: China

Facility:
Name: Research Site

Address:
City: Xining
Zip: 810001
Country: China

Facility:
Name: Research Site

Address:
City: Yangzhou
Zip: 225001
Country: China

Facility:
Name: Research Site

Address:
City: Zhanjiang
Zip: 524001
Country: China

Facility:
Name: Research Site

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Research Site

Address:
City: Zhengzhou
Zip: 450052
Country: China

Facility:
Name: Research Site

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: Research Site

Address:
City: Essen
Zip: 45122
Country: Germany

Facility:
Name: Research Site

Address:
City: Freiburg
Zip: 79106
Country: Germany

Facility:
Name: Research Site

Address:
City: Gauting
Zip: 82131
Country: Germany

Facility:
Name: Research Site

Address:
City: Hamburg
Zip: 20251
Country: Germany

Facility:
Name: Research Site

Address:
City: Hamburg
Zip: 21075
Country: Germany

Facility:
Name: Research Site

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: Research Site

Address:
City: Immenhausen
Zip: 34376
Country: Germany

Facility:
Name: Research Site

Address:
City: Mainz
Zip: 55131
Country: Germany

Facility:
Name: Research Site

Address:
City: Oldenburg
Zip: 26121
Country: Germany

Facility:
Name: Research Site

Address:
City: Würzburg
Zip: 97067
Country: Germany

Facility:
Name: Research Site

Address:
City: Shatin
Zip: 00000
Country: Hong Kong

Facility:
Name: Research Site

Address:
City: Budapest
Zip: 1083
Country: Hungary

Facility:
Name: Research Site

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Research Site

Address:
City: Kecskemét
Zip: 6000
Country: Hungary

Facility:
Name: Research Site

Address:
City: Miskolc
Zip: 3529
Country: Hungary

Facility:
Name: Research Site

Address:
City: Törökbálint
Zip: 2045
Country: Hungary

Facility:
Name: Research Site

Address:
City: Bunkyo-ku
Zip: 113-8603
Country: Japan

Facility:
Name: Research Site

Address:
City: Chuo-ku
Zip: 104-0045
Country: Japan

Facility:
Name: Research Site

Address:
City: Fukuoka-shi
Zip: 812-8582
Country: Japan

Facility:
Name: Research Site

Address:
City: Hiroshima-shi
Zip: 730-0011
Country: Japan

Facility:
Name: Research Site

Address:
City: Iwakuni-shi
Zip: 740-8510
Country: Japan

Facility:
Name: Research Site

Address:
City: Kanazawa
Zip: 920-8641
Country: Japan

Facility:
Name: Research Site

Address:
City: Kashiwa
Zip: 227-8577
Country: Japan

Facility:
Name: Research Site

Address:
City: Koto-ku
Zip: 135-8550
Country: Japan

Facility:
Name: Research Site

Address:
City: Kurume-shi
Zip: 830-0011
Country: Japan

Facility:
Name: Research Site

Address:
City: Matsuyama-shi
Zip: 790-0007
Country: Japan

Facility:
Name: Research Site

Address:
City: Okayama-shi
Zip: 700-8558
Country: Japan

Facility:
Name: Research Site

Address:
City: Okayama-shi
Zip: 700-8607
Country: Japan

Facility:
Name: Research Site

Address:
City: Osakasayama
Zip: 589-8511
Country: Japan

Facility:
Name: Research Site

Address:
City: Sapporo-shi
Zip: 003-0804
Country: Japan

Facility:
Name: Research Site

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: Research Site

Address:
City: Toyoake-shi
Zip: 470-1101
Country: Japan

Facility:
Name: Research Site

Address:
City: Ube-shi
Zip: 755-0241
Country: Japan

Facility:
Name: Research Site

Address:
City: Yokohama-shi
Zip: 236-0004
Country: Japan

Facility:
Name: Research Site

Address:
City: Yokohama-shi
Zip: 241-8515
Country: Japan

Facility:
Name: Research Site

Address:
City: Busan
Zip: 47392
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Chungcheongbuk-do
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Daegu
Zip: 42415
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Incheon
Zip: 21565
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 6351
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Ulsan
Zip: 44033
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Aguascalientes
Zip: 20230
Country: Mexico

Facility:
Name: Research Site

Address:
City: Cuautitlan Izcalli
Zip: 54769
Country: Mexico

Facility:
Name: Research Site

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: Research Site

Address:
City: Mexico City
Zip: 0 3100
Country: Mexico

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Name: Research Site

Address:
City: Mexico
Zip: 14080
Country: Mexico

Facility:
Name: Research Site

Address:
City: Monterrey
Zip: 64060
Country: Mexico

Facility:
Name: Research Site

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: Research Site

Address:
City: México
Zip: 04739
Country: Mexico

Facility:
Name: Research Site

Address:
City: Tuxtla
Zip: 29030
Country: Mexico

Facility:
Name: Research Site

Address:
City: Arequipa
Zip: AREQUIPA01
Country: Peru

Facility:
Name: Research Site

Address:
City: Lima
Zip: L27
Country: Peru

Facility:
Name: Research Site

Address:
City: Lima
Zip: LIMA 29
Country: Peru

Facility:
Name: Research Site

Address:
City: Lima
Zip: LIMA 34
Country: Peru

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Name: Research Site

Address:
City: Lima
Zip: LIMA 41
Country: Peru

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Name: Research Site

Address:
City: San Isidro
Zip: 27
Country: Peru

Facility:
Name: Research Site

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Research Site

Address:
City: Tomaszów Mazowiecki
Zip: 97-200
Country: Poland

Facility:
Name: Research Site

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Research Site

Address:
City: Wodzisław Śląski
Zip: 44-300
Country: Poland

Facility:
Name: Research Site

Address:
City: Moscow
Zip: 105229
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Moscow
Zip: 115280
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Moscow
Zip: 125367
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Omsk
Zip: 644013
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Saint Petersburg
Zip: 195271
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Saint-Petersburg
Zip: 194291
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Sankt-Peterburg
Zip: 196603
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Research Site

Address:
City: Durban
Zip: 4091
Country: South Africa

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Name: Research Site

Address:
City: Johannesburg
Zip: 0001
Country: South Africa

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Name: Research Site

Address:
City: Kraaifontein
Zip: 7570
Country: South Africa

Facility:
Name: Research Site

Address:
City: Parktown
Zip: 2193
Country: South Africa

Facility:
Name: Research Site

Address:
City: Pretoria
Zip: 0001
Country: South Africa

Facility:
Name: Research Site

Address:
City: Rondebosch
Zip: 7700
Country: South Africa

Facility:
Name: Research Site

Address:
City: Vereeniging
Zip: 1930
Country: South Africa

Facility:
Name: Research Site

Address:
City: Changhua City
Zip: 50006
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Kaohsiung City
Zip: 83301
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Kaohsiung
Zip: 82445
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Tainan
Zip: 70403
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Taipei
Zip: 112
Country: Taiwan

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Name: Research Site

Address:
City: Taipei
Zip: 235
Country: Taiwan

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Name: Research Site

Address:
City: Tao-Yuan
Zip: 333
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Bangkok
Zip: 10210
Country: Thailand

Facility:
Name: Research Site

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Facility:
Name: Research Site

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Facility:
Name: Research Site

Address:
City: Muang
Zip: 50200
Country: Thailand

Facility:
Name: Research Site

Address:
City: Songkhla
Zip: 90110
Country: Thailand

Facility:
Name: Research Site

Address:
City: Dnipro
Zip: 49102
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Ivano-Frankivsk
Zip: 76018
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Kirovohrad
Zip: 25006
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Kyiv
Zip: 03022
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Kyiv
Zip: 03115
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Lviv
Zip: 79031
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Odesa
Zip: 65055
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Sumy
Zip: 40022
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Vinnytsia
Zip: 21029
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Zaporizhzhia
Zip: 69040
Country: Ukraine

Facility:
Name: Research Site

Address:
City: Leicester
Zip: LE1 5WW
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: London
Zip: EC1M 6BQ
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: London
Zip: W6 8RF
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: Hanoi
Zip: 100000
Country: Vietnam

Facility:
Name: Research Site

Address:
City: Ho Chi Minh
Zip: 700000
Country: Vietnam

Start date: June 1, 2017

Completion date: December 31, 2026

Lead sponsor:
Agency: AstraZeneca
Agency class: Industry

Source: AstraZeneca

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03164616
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