Clinical trial NCT02657434: 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)
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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:

Cancer-Specific Exclusions

* 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

Exclusion Criteria Related to Medications and Chemotherapy:

* 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

Exclusion Criteria Related to Chemotherapy:

* 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

Primary outcomes:
measure: Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Randomization up to approximately 39 months
measure: Overall Survival (OS)
timeFrame: Randomization up to approximately 39 months
Secondary outcomes:
measure: Overall Survival Rate at Year 1
timeFrame: Year 1
measure: Overall Survival Rate Year 2
timeFrame: Year 2
measure: Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
timeFrame: Randomization up to approximately 25 months
measure: Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
timeFrame: Randomization up to approximately 25 months
measure: Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
timeFrame: Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
measure: Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
timeFrame: Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
measure: Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
timeFrame: Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
measure: Minimum Observed Serum Atezolizumab Concentration (Cmin)
timeFrame: Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months)
measure: Maximum Observed Serum Atezolizumab Concentration (Cmax)
timeFrame: Day 1 of Cycle 1 (Cycle length=21 days)
measure: Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
timeFrame: Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
measure: Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
timeFrame: Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
measure: Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
timeFrame: Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
timeFrame: Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Sebastopol
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Stamford
country: United States
facility: Stamford Hospital; BCC, MOHR
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health Inc.
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Tinley Park
country: United States
facility: HealthCare Research Network II, LLC - PPDS
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Med Oncology & Hematology Inc
state: Indiana
city: Goshen
country: United States
facility: Goshen Health System
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky; Markey Cancer Center
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Island
country: United States
facility: CHI Health St. Francis
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cary
country: United States
facility: Swedish Cancer Institute
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: Oncology Consultants PA
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists (Fairfax) - USOR
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Cordoba
country: Argentina
facility: Fundacion Clinica Colombo
city: Viedma
country: Argentina
facility: Clinica Viedma S.A.
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Adventist Hospital; Clinical Trial Unit
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital; Medical Oncology
state: New South Wales
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Ballarat
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Herstal
country: Belgium
facility: Clinique André Renard; Pneumologie
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Rumbeke), Apotheek
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: Santiago
country: Chile
facility: Health & Care SPA
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: Viña del Mar
country: Chile
facility: Hospital Clinico Vina del Mar?
city: Beijing Shi
country: China
facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changsha CITY
country: China
facility: Hunan Cancer Hospital
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou City
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University
city: Hefei
country: China
facility: Anhui Provincial Hospital; 2F,Tumor chemotherapy Department
city: Hefei
country: China
facility: Anhui Provincial Hospital; Respiratory Department
city: Jinan City
country: China
facility: Qilu Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenyang
country: China
facility: First Hospital of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bron
country: France
facility: Hopital Louis Pradel; Pneumologie
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal; Service de Pneumologie
city: Limoges
country: France
facility: Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
city: Marseille
country: France
facility: Hopital Nord AP-HM
city: Montpellier
country: France
facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller
city: Saint-Mande
country: France
facility: Hopital d'Instruction des Armees de Begin
city: Toulon
country: France
facility: Hopital d Instruction des Armees de Sainte Anne
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Szombathely
country: Hungary
facility: Markusovszky Hospital
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Dublin
country: Ireland
facility: Mater Misecordiae University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Petach Tiqwa
country: Israel
facility: Rabin Medical Center
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci
state: Emilia-Romagna
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: Lazio
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
state: Lazio
city: Orbassano (TO)
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
state: Piemonte
city: Lecce
country: Italy
facility: Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
state: Puglia
city: Taormina
country: Italy
facility: Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica
state: Sicilia
city: Lucca
country: Italy
facility: Ospedale San Luca - USL2 Lucca
state: Toscana
city: Aichi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
city: Hyogo
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Yamaguchi
country: Japan
facility: National Hospital Organization Yamaguchi - Ube Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital Latvian Oncology Centre
city: Panevezys
country: Lithuania
facility: Panevezys Hospital
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: FED. Territory OF Kuala Lumpur
city: Kepala Batas
country: Malaysia
facility: Advanced Medical and Dental Institute; Kompleks Klinikal
state: Penang
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: EDE
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Tilburg
country: Netherlands
facility: ETZ TweeSteden
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos SA
city: Senhora Da Hora - Porto
country: Portugal
facility: Hospital CUF Porto; Servico de Imunoalergologia
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
city: Iasi
country: Romania
facility: Euroclinic Center of Oncology SRL
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary
state: Moskovskaja Oblast
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Oncologia
state: Alicante
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO L'Hospitalet; Servicio de oncologia medica
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: Mataro
country: Spain
facility: Hospital de Mataro
state: Cantabria
city: Donostia
country: Spain
facility: Onkologikoa; Ensayos Clinicos
state: Guipuzcoa
city: A Coruna
country: Spain
facility: Centro Oncologico de Galicia COG; Medical Oncology
state: LA Coruña
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
state: Murcia
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oncologia
state: Navarra
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra; Servicio de Oncologia
state: Navarra
city: Seville
country: Spain
facility: Complejo Hospitalario Nuestra Senora de Valme
state: Sevilla
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
city: Burgos
country: Spain
facility: C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Oncologia
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: HM Sanchinarro ? CIOCC
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Dalin, Chiayi
country: Taiwan
facility: Buddhist Dalin Tzuchi General Hospital
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital; Chest
city: Liuying Township
country: Taiwan
facility: Chi Mei Medical Center Liou Ying Campus
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Internal Medicine
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Dnipropetrovsk
country: Ukraine
facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
state: Katerynoslav Governorate
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept
state: Kharkiv Governorate
city: Cherkasy
country: Ukraine
facility: MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology
city: Kirovograd
country: Ukraine
facility: Private Enterprise Private Manufacturing Company Acinus
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department
city: Zaporizhzhya
country: Ukraine
facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology centre
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital; Beatson West of Scotland Cancer Centre
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: London
country: United Kingdom
facility: St George?s Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Plymouth Oncology Centre
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.