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.
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.
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.
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There are 169 Locations for this study
Phoenix Arizona, 85054, United States
Bakersfield California, 93309, United States
Santa Monica California, 90404, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32224, United States
Saint Petersburg Florida, 33705, United States
West Palm Beach Florida, 33401, United States
Louisville Kentucky, 40202, United States
Kansas City Missouri, 64132, United States
Canton Ohio, 44710, United States
Pittsburgh Pennsylvania, 15212, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77090, United States
Richmond Virginia, 23298, United States
Barretos , 14784, Brazil
Belo Horizonte , 30380, Brazil
Curitiba , 81520, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Porto Alegre , 91350, Brazil
Ribeirao Preto , 14015, Brazil
Rio de Janeiro , 20231, Brazil
Santo Andre , 09080, Brazil
Santo André , 09060, Brazil
Sao Paulo , 01209, Brazil
Sao Paulo , 01246, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 03102, Brazil
Plovdiv , 4000, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1618, Bulgaria
Sofia , 1784, Bulgaria
Varna , 9010, Bulgaria
Beijing , 10002, China
Beijing , 10014, China
Changchun , 13001, China
Changsha , 41001, China
Fuzhou , 35001, China
Guangzhou , 51008, China
Hangzhou , 31002, China
Harbin , 15008, China
Hefei , 23060, China
Kunming , CN-65, China
Linyi , 27600, China
Liuzhou , 54500, China
Nanjing , 21000, China
Qingdao , 11001, China
Shanghai , 20003, China
Shanghai , 20003, China
Shanghai , 20008, China
Shantou , 51504, China
Wuhan , 43002, China
Wuhan , 43007, China
Xining , 81000, China
Yangzhou , 22500, China
Zhanjiang , 52400, China
Zhengzhou , 45000, China
Zhengzhou , 45005, China
Berlin , 13125, Germany
Essen , 45122, Germany
Freiburg , 79106, Germany
Gauting , 82131, Germany
Hamburg , 20251, Germany
Hamburg , 21075, Germany
Heidelberg , 69126, Germany
Immenhausen , 34376, Germany
Mainz , 55131, Germany
Oldenburg , 26121, Germany
Würzburg , 97067, Germany
Shatin , 00000, Hong Kong
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Kecskemét , 6000, Hungary
Miskolc , 3529, Hungary
Törökbálint , 2045, Hungary
Bunkyo-ku , 113-8, Japan
Chuo-ku , 104-0, Japan
Fukuoka-shi , 812-8, Japan
Hiroshima-shi , 730-0, Japan
Iwakuni-shi , 740-8, Japan
Kanazawa , 920-8, Japan
Kashiwa , 227-8, Japan
Koto-ku , 135-8, Japan
Kurume-shi , 830-0, Japan
Matsuyama-shi , 790-0, Japan
Okayama-shi , 700-8, Japan
Okayama-shi , 700-8, Japan
Osakasayama , 589-8, Japan
Sapporo-shi , 003-0, Japan
Sunto-gun , 411-8, Japan
Toyoake-shi , 470-1, Japan
Ube-shi , 755-0, Japan
Yokohama-shi , 236-0, Japan
Yokohama-shi , 241-8, Japan
Busan , 47392, Korea, Republic of
Chungcheongbuk-do , 28644, Korea, Republic of
Daegu , 42415, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Aguascalientes , 20230, Mexico
Cuautitlan Izcalli , 54769, Mexico
Guadalajara , 44280, Mexico
Mexico City , 0 310, Mexico
Mexico , 14080, Mexico
Monterrey , 64060, Mexico
Monterrey , 64460, Mexico
México , 04739, Mexico
Tuxtla , 29030, Mexico
Arequipa , AREQU, Peru
Lima , L27, Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
San Isidro , 27, Peru
Olsztyn , 10-35, Poland
Tomaszów Mazowiecki , 97-20, Poland
Warszawa , 02-78, Poland
Wodzisław Śląski , 44-30, Poland
Moscow , 10522, Russian Federation
Moscow , 11528, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12536, Russian Federation
Omsk , 64401, Russian Federation
Saint Petersburg , 19527, Russian Federation
Saint-Petersburg , 19429, Russian Federation
Sankt-Peterburg , 19660, Russian Federation
St. Petersburg , 19775, Russian Federation
Durban , 4091, South Africa
Johannesburg , 0001, South Africa
Kraaifontein , 7570, South Africa
Parktown , 2193, South Africa
Pretoria , 0001, South Africa
Rondebosch , 7700, South Africa
Vereeniging , 1930, South Africa
Changhua City , 50006, Taiwan
Kaohsiung City , 83301, Taiwan
Kaohsiung , 82445, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Taipei , 235, Taiwan
Tao-Yuan , 333, Taiwan
Bangkok , 10210, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Muang , 50200, Thailand
Songkhla , 90110, Thailand
Dnipro , 49102, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kirovohrad , 25006, Ukraine
Kyiv , 03022, Ukraine
Kyiv , 03115, Ukraine
Lviv , 79031, Ukraine
Odesa , 65055, Ukraine
Sumy , 40022, Ukraine
Vinnytsia , 21029, Ukraine
Zaporizhzhia , 69040, Ukraine
Leicester , LE1 5, United Kingdom
London , EC1M , United Kingdom
London , NW1 2, United Kingdom
London , W6 8R, United Kingdom
Manchester , M20 4, United Kingdom
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
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