Lung Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

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.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1193

Study ID:

NCT03164616

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 177 Locations for this study

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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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Saint 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, Brazil
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Belo Horizonte , 30380, Brazil
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Curitiba , 81520, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90610, Brazil
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Porto Alegre , 91350, Brazil
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Ribeirao Preto , 14015, Brazil
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Rio de Janeiro , 20231, Brazil
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Santo Andre , 09080, Brazil
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Santo André , 09060, Brazil
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Sao Paulo , 01209, Brazil
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Sao Paulo , 01246, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 03102, 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 , 10002, China
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Beijing , 10005, China
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Beijing , 10014, China
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Changchun , 13001, China
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Changsha , 41001, China
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Fuzhou , 35001, China
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Guangzhou , 51008, China
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Hangzhou , 31002, China
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Harbin , 15008, China
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He Fei , 23002, China
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Hefei , 23000, China
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Hefei , 23060, China
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Jinan , 25011, China
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Kunming , 65011, China
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Kunming , CN-65, China
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Linyi , 27600, China
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Liuzhou , 54500, China
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Nanjing , 21000, China
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Qingdao , 11001, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shanghai , 20008, China
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Shanghai , 20043, China
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Shantou , 51504, China
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Wenzhou , 32501, China
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Wuhan , 43002, China
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Wuhan , 43007, China
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Xi'an , 71000, China
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Xining , 81000, China
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Yangzhou , 22500, China
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Zhanjiang , 52400, China
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Zhengzhou , 45000, China
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Zhengzhou , 45005, China
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Berlin , 13125, Germany
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Essen , 45122, Germany
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Freiburg , 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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Bunkyo-ku , 113-8, Japan
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Chuo-ku , 104-0, Japan
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Fukuoka-shi , 812-8, Japan
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Hiroshima-shi , 730-0, Japan
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Iwakuni-shi , 740-8, Japan
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Kanazawa , 920-8, Japan
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Kashiwa , 227-8, Japan
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Koto-ku , 135-8, Japan
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Kurume-shi , 830-0, Japan
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Matsuyama-shi , 790-0, Japan
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Okayama-shi , 700-8, Japan
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Okayama-shi , 700-8, Japan
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Osakasayama , 589-8, Japan
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Sapporo-shi , 003-0, Japan
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Sunto-gun , 411-8, Japan
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Toyoake-shi , 470-1, Japan
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Ube-shi , 755-0, Japan
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Yokohama-shi , 236-0, Japan
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Yokohama-shi , 241-8, Japan
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Busan , 47392, Korea, Republic of
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Chungcheongbuk-do , 28644, Korea, Republic of
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Daegu , 42415, Korea, Republic of
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Incheon , 21565, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
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Ulsan , 44033, Korea, Republic of
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Aguascalientes , 20230, Mexico
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Cuautitlan Izcalli , 54769, Mexico
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Guadalajara , 44280, Mexico
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Mexico City , 0 310, Mexico
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Mexico , 14080, Mexico
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Monterrey , 64060, Mexico
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Monterrey , 64460, Mexico
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México , 04739, Mexico
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Tuxtla , 29030, Mexico
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Arequipa , AREQU, Peru
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Lima , L27, Peru
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Lima , LIMA , Peru
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Lima , LIMA , Peru
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Lima , LIMA , Peru
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San Isidro , 27, Peru
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Olsztyn , 10-35, Poland
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Tomaszów Mazowiecki , 97-20, Poland
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Warszawa , 02-78, Poland
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Wodzisław Śląski , 44-30, Poland
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Moscow , 10522, Russian Federation
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Moscow , 11528, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 12536, Russian Federation
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Omsk , 64401, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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Saint-Petersburg , 19429, Russian Federation
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Sankt-Peterburg , 19660, Russian Federation
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St. Petersburg , 19775, Russian Federation
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Durban , 4091, South Africa
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Johannesburg , 0001, South Africa
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Kraaifontein , 7570, 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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Changhua City , 50006, Taiwan
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Kaohsiung City , 83301, Taiwan
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Kaohsiung , 82445, 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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Tao-Yuan , 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 5, United Kingdom
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London , EC1M , United Kingdom
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London , NW1 2, United Kingdom
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London , W6 8R, United Kingdom
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Manchester , M20 4, United Kingdom
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Hanoi , 10000, Vietnam
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1193

Study ID:

NCT03164616

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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