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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)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Carboplatin
Cisplatin
Pemetrexed
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Angeles Hematology Oncology Medical Group
  • St. Joseph Heritage Healthcare
  • Stamford Hospital; BCC, MOHR
  • Orlando Health Inc.
  • Tallahassee Memorial Hospital
  • Northside Hospital
  • Ingalls Memorial Hospital
  • Illinois Cancer Care
  • HealthCare Research Network II, LLC - PPDS
  • Fort Wayne Med Oncology & Hematology Inc
  • Goshen Health System
  • University of Kentucky; Markey Cancer Center
  • University of Michigan
  • CHI Health St. Francis
  • Nebraska Methodist Hospital
  • Montefiore Medical Center
  • Swedish Cancer Institute
  • Providence Portland Medical Center
  • Gettysburg Cancer Center
  • Allegheny Cancer Center
  • Oncology Consultants PA
  • Virginia Cancer Specialists (Fairfax) - USOR
  • Peninsula Cancer Institute
  • Blue Ridge Cancer Care
  • University of Washington
  • St. Vincent Hospital
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • Fundacion Clinica Colombo
  • Centro de Investigacion; Clinica - Clinica Viedma S.A.
  • St Vincent's Hospital Sydney
  • Sydney Adventist Hospital; Clinical Trial Unit
  • St George Hospital; Medical Oncology
  • Redcliffe Hospital
  • Mater Adult Hospital
  • Royal Hobart Hospital
  • Ballarat Health Services
  • Peninsula and South Eastern Haematology and Oncology Group
  • Barwon Health
  • Klinikum Wels-Grieskirchen GmbH
  • AZ Maria Middelares
  • Clinique André Renard; Pneumologie
  • AZ Delta (Campus Rumbeke), Apotheek
  • Multiprofile Hospital for Active Treatment Serdika EOOD
  • Health & Care SPA
  • Sociedad de Investigaciones Medicas Ltda (SIM)
  • Hospital Clinico Vina del Mar
  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science
  • Beijing Cancer Hospital
  • Hunan Cancer Hospital
  • Changzhou First People's Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Medical School of Zhejiang University
  • Sir Run Run Shaw Hospital Zhejiang University
  • Anhui Provincial Hospital; 2F,Tumor chemotherapy Department
  • Anhui Provincial Hospital; Respiratory Department
  • Qilu Hospital
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Shanghai Chest Hospital
  • Zhongshan Hospital Fudan University
  • First Hospital of China Medical University
  • Tianjin Medical University Cancer Institute & Hospital
  • Tianjin Medical University General Hospital
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Zhejiang Cancer Hospital
  • Institut Sainte Catherine
  • Hopital Louis Pradel; Pneumologie
  • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
  • Centre Hospitalier Intercommunal; Service de Pneumologie
  • Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
  • Hopital Nord AP-HM
  • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
  • Centre Hospitalier de Mulhouse - Hopital Emile Muller
  • Hopital d'Instruction des Armees de Begin
  • Hopital d Instruction des Armees de Sainte Anne
  • Veszprem Megyei Tudogyogyintezet
  • Petz Aladar Megyei Oktato Korhaz
  • Markusovszky Hospital
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tudogyogyintezet Torokbalint
  • Mater Misecordiae University Hospital
  • St James's Hospital
  • Barzilai Medical Center
  • Edith Wolfson Medical Center
  • Rabin Medical Center
  • Azienda Ospedaliero Universitaria di Parma
  • Ospedale Santa Maria Delle Croci
  • Istituto Nazionale Tumori Regina Elena
  • Azienda Policlinico Umberto I
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
  • Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
  • Ospedale Casa Sollievo Della Sofferenza IRCCS
  • Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica
  • Ospedale San Luca - USL2 Lucca
  • National Hospital Organization Nagoya Medical Center
  • National Cancer Center Hospital East
  • Hiroshima University Hospital
  • National Hospital Organization Asahikawa Medical Center
  • National Hospital Organization Himeji Medical Center
  • Kanazawa University Hospital
  • Kagoshima University Hospital
  • Kanagawa Cancer Center
  • Tohoku University Hospital
  • Niigata University Medical & Dental Hospital
  • Osaka University Hospital
  • Osaka Medical College Hospital
  • Saga University Hospital
  • Tokushima University Hospital
  • Juntendo University Hospital
  • Nippon Medical School Hospital
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  • The Cancer Institute Hospital of JFCR
  • NTT Medical Center Tokyo
  • National Hospital Organization Yamaguchi - Ube Medical Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Riga East Clinical University Hospital Latvian Oncology Centre
  • Panevezys Hospital
  • Advanced Medical and Dental Institute; Kompleks Klinikal
  • Hospital Kuala Lumpur
  • Amphia Ziekenhuis
  • Haga Ziekenhuis
  • Ziekenhuis Gelderse Vallei
  • Ziekenhuis St. Jansdal
  • Zuyderland Medisch Centrum - Sittard Geleen
  • ETZ TweeSteden
  • Hospital Nacional Cayetano Heredia
  • Hospital Beatriz Angelo
  • Unidade Local de Saude de Matosinhos SA
  • Hospital CUF Porto; Servico de Imunoalergologia
  • Medisprof SRL
  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
  • Euroclinic Center of Oncology SRL
  • Chelyabinsk Regional Clinical Oncology Dispensary
  • Moscow City Oncology Hospital #62
  • Regional Clinical Oncology Hospital
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Hospital Universitario Germans Trias i Pujol
  • ICO L'Hospitalet; Servicio de oncologia medica
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital de Mataro
  • Onkologikoa; Ensayos Clinicos
  • Centro Oncologico de Galicia COG; Medical Oncology
  • Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Complejo Hospitalario de Navarra; Servicio de Oncologia
  • Complejo Hospitalario Nuestra Senora de Valme
  • Hospital General Univ. de Alicante
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia
  • Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
  • Hospital Lucus Augusti; Servicio de Oncologia
  • MD Anderson Cancer Center
  • Hospital Universitario Ramon y Cajal
  • HM Sanchinarro - CIOCC
  • Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Buddhist Dalin Tzuchi General Hospital
  • E-DA Hospital; Chest
  • Chi Mei Medical Center Liou Ying Campus
  • Taipei Veterans General Hospital
  • National Taiwan Uni Hospital; Internal Medicine
  • Tri-Service General Hospital
  • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
  • Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept
  • MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology
  • Private Enterprise Private Manufacturing Company Acinus
  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department
  • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
  • Bristol Haematology and Oncology Centre
  • Velindre Hospital
  • Gartnavel General Hospital; Beatson West of Scotland Cancer Centre
  • Raigmore Hospital
  • St George's Hospital
  • Charing Cross Hospital
  • Churchill Hospital
  • Derriford Hospital; Plymouth Oncology Centre
  • Queen's Hospital
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed

Arm B (Carboplatin or Cisplatin + Pemetrexed)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.
Overall Survival (OS)
OS is defined as time from randomization to death from any cause.

Secondary Outcome Measures

Overall Survival Rate at Year 1
The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization.
Overall Survival Rate Year 2
The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response.
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.
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
EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)

Full Information

First Posted
January 14, 2016
Last Updated
January 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02657434
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2016 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
578 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (Carboplatin or Cisplatin + Pemetrexed)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL3280A; TECENTRIQ
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Description
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.
Time Frame
Randomization up to approximately 39 months
Title
Overall Survival (OS)
Description
OS is defined as time from randomization to death from any cause.
Time Frame
Randomization up to approximately 39 months
Secondary Outcome Measure Information:
Title
Overall Survival Rate at Year 1
Description
The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization.
Time Frame
Year 1
Title
Overall Survival Rate Year 2
Description
The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.
Time Frame
Year 2
Title
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
Description
An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response.
Time Frame
Randomization up to approximately 25 months
Title
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
Description
DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.
Time Frame
Randomization up to approximately 25 months
Title
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
Description
EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Time Frame
Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Title
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Description
The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Time Frame
Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Title
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Description
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
Time Frame
Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Title
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Description
Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)
Time Frame
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)
Title
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Description
Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)
Time Frame
Day 1 of Cycle 1 (Cycle length=21 days)
Title
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Time Frame
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)
Title
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Time Frame
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)
Title
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Time Frame
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)
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
Description
Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Los Angeles Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Sebastopol
State/Province
California
ZIP/Postal Code
95472
Country
United States
Facility Name
Stamford Hospital; BCC, MOHR
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Orlando Health Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
HealthCare Research Network II, LLC - PPDS
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60487
Country
United States
Facility Name
Fort Wayne Med Oncology & Hematology Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
University of Kentucky; Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0934
Country
United States
Facility Name
CHI Health St. Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Swedish Cancer Institute
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Oncology Consultants PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Cancer Specialists (Fairfax) - USOR
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Buenos Aires
ZIP/Postal Code
00001428
Country
Argentina
Facility Name
Fundacion Clinica Colombo
City
Cordoba
ZIP/Postal Code
X5002AOQ
Country
Argentina
Facility Name
Centro de Investigacion; Clinica - Clinica Viedma S.A.
City
Viedma
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Sydney Adventist Hospital; Clinical Trial Unit
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
St George Hospital; Medical Oncology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Redcliffe Hospital
City
Redcliffe
State/Province
Queensland
ZIP/Postal Code
4020
Country
Australia
Facility Name
Mater Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Ballarat Health Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinique André Renard; Pneumologie
City
Herstal
ZIP/Postal Code
4040
Country
Belgium
Facility Name
AZ Delta (Campus Rumbeke), Apotheek
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Multiprofile Hospital for Active Treatment Serdika EOOD
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Health & Care SPA
City
Santiago
ZIP/Postal Code
7500006
Country
Chile
Facility Name
Sociedad de Investigaciones Medicas Ltda (SIM)
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Hospital Clinico Vina del Mar
City
Viña del Mar
ZIP/Postal Code
2520612
Country
Chile
Facility Name
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
City
Beijing Shi
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Facility Name
Changzhou First People's Hospital
City
Changzhou
ZIP/Postal Code
213003
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310016
Country
China
Facility Name
Anhui Provincial Hospital; 2F,Tumor chemotherapy Department
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Anhui Provincial Hospital; Respiratory Department
City
Hefei
ZIP/Postal Code
230088
Country
China
Facility Name
Qilu Hospital
City
Jinan City
ZIP/Postal Code
250012
Country
China
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjing
ZIP/Postal Code
300060
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Facility Name
Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430023
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Hopital Louis Pradel; Pneumologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Intercommunal; Service de Pneumologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
City
Limoges
ZIP/Postal Code
87039
Country
France
Facility Name
Hopital Nord AP-HM
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Hospitalier de Mulhouse - Hopital Emile Muller
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Hopital d'Instruction des Armees de Begin
City
Saint-Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Hopital d Instruction des Armees de Sainte Anne
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
Veszprem Megyei Tudogyogyintezet
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Markusovszky Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Mater Misecordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tiqwa
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
Ospedale Santa Maria Delle Croci
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
City
Orbassano (TO)
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
City
Lecce
State/Province
Puglia
ZIP/Postal Code
73044
Country
Italy
Facility Name
Ospedale Casa Sollievo Della Sofferenza IRCCS
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica
City
Taormina
State/Province
Sicilia
ZIP/Postal Code
98039
Country
Italy
Facility Name
Ospedale San Luca - USL2 Lucca
City
Lucca
State/Province
Toscana
ZIP/Postal Code
55100
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
National Hospital Organization Yamaguchi - Ube Medical Center
City
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Riga East Clinical University Hospital Latvian Oncology Centre
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Panevezys Hospital
City
Panevezys
ZIP/Postal Code
35144
Country
Lithuania
Facility Name
Advanced Medical and Dental Institute; Kompleks Klinikal
City
Kepala Batas
State/Province
Penang
ZIP/Postal Code
13200
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
ZIP/Postal Code
2547 EX
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
EDE
ZIP/Postal Code
6716 RP
Country
Netherlands
Facility Name
Ziekenhuis St. Jansdal
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
ETZ TweeSteden
City
Tilburg
ZIP/Postal Code
5042AD
Country
Netherlands
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Unidade Local de Saude de Matosinhos SA
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Facility Name
Hospital CUF Porto; Servico de Imunoalergologia
City
Senhora Da Hora - Porto
ZIP/Postal Code
4460-188
Country
Portugal
Facility Name
Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Euroclinic Center of Oncology SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Chelyabinsk Regional Clinical Oncology Dispensary
City
Chelyabinsk
State/Province
Moskovskaja Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
ICO L'Hospitalet; Servicio de oncologia medica
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital de Mataro
City
Mataro
State/Province
Cantabria
ZIP/Postal Code
08304
Country
Spain
Facility Name
Onkologikoa; Ensayos Clinicos
City
Donostia
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Centro Oncologico de Galicia COG; Medical Oncology
City
A Coruna
State/Province
LA Coruña
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario Nuestra Senora de Valme
City
Seville
State/Province
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital General Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Lucus Augusti; Servicio de Oncologia
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
HM Sanchinarro - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Buddhist Dalin Tzuchi General Hospital
City
Dalin, Chiayi
ZIP/Postal Code
622
Country
Taiwan
Facility Name
E-DA Hospital; Chest
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
Chi Mei Medical Center Liou Ying Campus
City
Liuying Township
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
City
Dnipropetrovsk
State/Province
Katerynoslav Governorate
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept
City
Kyiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
02096
Country
Ukraine
Facility Name
MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Private Enterprise Private Manufacturing Company Acinus
City
Kirovograd
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
City
Zaporizhzhya
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Velindre Hospital
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Gartnavel General Hospital; Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UV
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Derriford Hospital; Plymouth Oncology Centre
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Queen's Hospital
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36052772
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.
Results Reference
derived
PubMed Identifier
35511917
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.
Results Reference
derived

Learn more about this trial

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)

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