A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
NCT ID: NCT02657434
Last Updated: 2023-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
578 participants
INTERVENTIONAL
2016-04-30
2022-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Atezolizumab
Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Carboplatin
Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.
Cisplatin
Participants received IV infusion of 75 mg/m\^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.
Pemetrexed
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Arm B (Carboplatin or Cisplatin + Pemetrexed)
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Carboplatin
Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.
Cisplatin
Participants received IV infusion of 75 mg/m\^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.
Pemetrexed
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Interventions
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Atezolizumab
Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Carboplatin
Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.
Cisplatin
Participants received IV infusion of 75 mg/m\^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.
Pemetrexed
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are eligible if the major histological component appears to be non-squamous
* No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and ALK status require test results at screening from a local or central laboratory
* Participants who have received prior neo-adjuvant, radiotherapy, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy
* Participants should submit a pre-treatment tumor tissue sample if available before or within 4 weeks after enrollment. If tumor tissue is not available, participants are still eligible
* For participants enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function
* For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of cisplatin
* For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Exclusion Criteria
* Participants with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than or equal to (\>= 2) weeks prior to randomization
* Leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled or symptomatic hypercalcemia (greater than \[\>\] 1.5 millimole/Liter ionized calcium or calcium \>12 milligrams/deciliter or corrected serum calcium \>upper limit of normal)
* Malignancies other than NSCLC within 5 years prior to randomization
* Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not eligible are excluded)
General Medical Exclusions:
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* History of certain autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
* All participants will be tested for human immunodeficiency virus (HIV) prior to the inclusion into the study and HIV-positive participants will be excluded from the clinical study
* Severe infections within 4 weeks prior to randomization
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
* Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
* Prior treatment with EGFR inhibitors or ALK inhibitors
* Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to initiation of study treatment
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
* Treatment with systemic immunosuppressive medications
* History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
* Participants with hearing impairment (cisplatin)
* Grade \>=2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)
* Creatinine clearance (CRCL) \<60 milliliters/minute (mL/min) for cisplatin or \<45 mL/min for carboplatin
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
St. Joseph Heritage Healthcare
Sebastopol, California, United States
Stamford Hospital; BCC, MOHR
Stamford, Connecticut, United States
Orlando Health Inc.
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
HealthCare Research Network II, LLC - PPDS
Tinley Park, Illinois, United States
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne, Indiana, United States
Goshen Health System
Goshen, Indiana, United States
University of Kentucky; Markey Cancer Center
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
CHI Health St. Francis
Grand Island, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
Swedish Cancer Institute
Cary, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Oncology Consultants PA
Houston, Texas, United States
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
University of Washington
Seattle, Washington, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, , Argentina
Fundacion Clinica Colombo
Córdoba, , Argentina
Clinica Viedma S.A.
Viedma, , Argentina
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Sydney Adventist Hospital; Clinical Trial Unit
Sydney, New South Wales, Australia
St George Hospital; Medical Oncology
Sydney, New South Wales, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Ballarat Health Services
Ballarat, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
AZ Maria Middelares
Ghent, , Belgium
Clinique André Renard; Pneumologie
Herstal, , Belgium
AZ Delta (Campus Rumbeke), Apotheek
Roeselare, , Belgium
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, , Bulgaria
Health & Care SPA
Santiago, , Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, , Chile
Hospital Clinico Vina del Mar?
Viña del Mar, , Chile
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
Changzhou First People's Hospital
Changzhou, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, , China
Anhui Provincial Hospital; 2F,Tumor chemotherapy Department
Hefei, , China
Anhui Provincial Hospital; Respiratory Department
Hefei, , China
Qilu Hospital
Jinan, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Shanghai Chest Hospital
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
First Hospital of China Medical University
Shenyang, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Institut Sainte Catherine
Avignon, , France
Hopital Louis Pradel; Pneumologie
Bron, , France
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
Clermont-Ferrand, , France
Centre Hospitalier Intercommunal; Service de Pneumologie
Créteil, , France
Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
Limoges, , France
Hopital Nord AP-HM
Marseille, , France
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
Montpellier, , France
Centre Hospitalier de Mulhouse - Hopital Emile Muller
Mulhouse, , France
Hopital d'Instruction des Armees de Begin
Saint-Mandé, , France
Hopital d Instruction des Armees de Sainte Anne
Toulon, , France
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Markusovszky Hospital
Szombathely, , Hungary
Tudogyogyintezet Torokbalint
Törökbálint, , Hungary
Mater Misecordiae University Hospital
Dublin, , Ireland
St James's Hospital
Dublin, , Ireland
Barzilai Medical Center
Ashkelon, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Rabin Medical Center
Petach Tiqwa, , Israel
Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
Lecce, Apulia, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Apulia, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, Italy
Ospedale Santa Maria Delle Croci
Ravenna, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Lazio, Italy
Azienda Policlinico Umberto I
Rome, Lazio, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
Orbassano (TO), Piedmont, Italy
Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica
Taormina, Sicily, Italy
Ospedale San Luca - USL2 Lucca
Lucca, Tuscany, Italy
National Hospital Organization Nagoya Medical Center
Aichi, , Japan
National Cancer Center Hospital East
Chiba, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
National Hospital Organization Asahikawa Medical Center
Hokkaido, , Japan
National Hospital Organization Himeji Medical Center
Hyōgo, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Tohoku University Hospital
Miyagi, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka University Hospital
Osaka, , Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, , Japan
Saga University Hospital
Saga, , Japan
Tokushima University Hospital
Tokushima, , Japan
Juntendo University Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
NTT Medical Center Tokyo
Tokyo, , Japan
National Hospital Organization Yamaguchi - Ube Medical Center
Yamaguchi, , Japan
Riga East Clinical University Hospital Latvian Oncology Centre
Riga, , Latvia
Panevezys Hospital
Panevezys, , Lithuania
Hospital Kuala Lumpur
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
Advanced Medical and Dental Institute; Kompleks Klinikal
Kepala Batas, Pulau Pinang, Malaysia
Amphia Ziekenhuis
Breda, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Ziekenhuis St. Jansdal
Harderwijk, , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
ETZ TweeSteden
Tilburg, , Netherlands
Hospital Nacional Cayetano Heredia
Lima, , Peru
Hospital Beatriz Angelo
Loures, , Portugal
Unidade Local de Saude de Matosinhos SA
Matosinhos Municipality, , Portugal
Hospital CUF Porto; Servico de Imunoalergologia
Senhora Da Hora - Porto, , Portugal
Medisprof SRL
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Constanța, , Romania
Euroclinic Center of Oncology SRL
Iași, , Romania
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, Moscow Oblast, Russia
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
ICO L'Hospitalet; Servicio de oncologia medica
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, Spain
Hospital de Mataro
Mataro, Cantabria, Spain
Onkologikoa; Ensayos Clinicos
Donostia / San Sebastian, Guipuzcoa, Spain
Centro Oncologico de Galicia COG; Medical Oncology
A Coruña, LA Coruña, Spain
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
El Palmar, Murcia, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarre, Spain
Complejo Hospitalario de Navarra; Servicio de Oncologia
Pamplona, Navarre, Spain
Complejo Hospitalario Nuestra Senora de Valme
Seville, Sevilla, Spain
Hospital General Univ. de Alicante
Alicante, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
Barcelona, , Spain
C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia
Burgos, , Spain
Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
Girona, , Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
HM Sanchinarro ? CIOCC
Madrid, , Spain
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
Málaga, , Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Buddhist Dalin Tzuchi General Hospital
Dalin, Chiayi, , Taiwan
E-DA Hospital; Chest
Kaohsiung City, , Taiwan
Chi Mei Medical Center Liou Ying Campus
Liuying Township, , Taiwan
National Taiwan Uni Hospital; Internal Medicine
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, Katerynoslav Governorate, Ukraine
Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept
Kyiv, Kharkiv Governorate, Ukraine
MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology
Cherkasy, , Ukraine
Private Enterprise Private Manufacturing Company Acinus
Kirovograd, , Ukraine
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department
Sumy, , Ukraine
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
Zaporizhzhya, , Ukraine
Bristol Haematology and Oncology centre
Bristol, , United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Gartnavel General Hospital; Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
St George?s Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Derriford Hospital; Plymouth Oncology Centre
Plymouth, , United Kingdom
Queen's Hospital
Romford, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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References
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Socinski MA, Jotte RM, Cappuzzo F, Nishio M, Mok TSK, Reck M, Finley GG, Kaul MD, Yu W, Paranthaman N, Bara I, West HJ. Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials. JAMA Oncol. 2023 Apr 1;9(4):527-535. doi: 10.1001/jamaoncol.2022.7711.
Lu S, Fang J, Wang Z, Fan Y, Liu Y, He J, Zhou J, Hu J, Xia J, Liu W, Shi J, Yi J, Cao L. Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer. Cancer Med. 2023 Feb;12(3):2666-2676. doi: 10.1002/cam4.5144. Epub 2022 Sep 2.
Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003605-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29438
Identifier Type: -
Identifier Source: org_study_id
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