NCT02657434

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
578

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Apr 2016

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
26 countries

182 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

April 30, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 9, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

January 14, 2016

Results QC Date

July 7, 2020

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Randomization up to approximately 39 months

  • Overall Survival (OS)

    OS is defined as time from randomization to death from any cause.

    Randomization up to approximately 39 months

Secondary Outcomes (13)

  • Overall Survival Rate at Year 1

    Year 1

  • Overall Survival Rate Year 2

    Year 2

  • Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1

    Randomization up to approximately 25 months

  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1

    Randomization up to approximately 25 months

  • 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

    Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)

  • +8 more secondary outcomes

Study Arms (2)

Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed

EXPERIMENTAL

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.

Drug: AtezolizumabDrug: CarboplatinDrug: CisplatinDrug: Pemetrexed

Arm B (Carboplatin or Cisplatin + Pemetrexed)

ACTIVE COMPARATOR

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.

Drug: CarboplatinDrug: CisplatinDrug: Pemetrexed

Interventions

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.

Also known as: MPDL3280A, TECENTRIQ
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed

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.

Arm A (Atezolizumab + Carboplatin or Cisplatin + PemetrexedArm B (Carboplatin or Cisplatin + Pemetrexed)

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.

Arm A (Atezolizumab + Carboplatin or Cisplatin + PemetrexedArm B (Carboplatin or Cisplatin + 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 A (Atezolizumab + Carboplatin or Cisplatin + PemetrexedArm B (Carboplatin or Cisplatin + Pemetrexed)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (183)

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

St. Joseph Heritage Healthcare

Sebastopol, California, 95472, United States

Location

Stamford Hospital; BCC, MOHR

Stamford, Connecticut, 06904, United States

Location

Orlando Health Inc.

Orlando, Florida, 32806, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

HealthCare Research Network II, LLC - PPDS

Tinley Park, Illinois, 60487, United States

Location

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, 46845, United States

Location

Goshen Health System

Goshen, Indiana, 46526, United States

Location

University of Kentucky; Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0934, United States

Location

CHI Health St. Francis

Grand Island, Nebraska, 68803, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Swedish Cancer Institute

Cary, North Carolina, 27513, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Oncology Consultants PA

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists (Fairfax) - USOR

Fairfax, Virginia, 22031, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54311, United States

Location

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Buenos Aires, 00001428, Argentina

Location

Fundacion Clinica Colombo

Córdoba, X5002AOQ, Argentina

Location

Clinica Viedma S.A.

Viedma, R8500ACE, Argentina

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Sydney Adventist Hospital; Clinical Trial Unit

Sydney, New South Wales, 2076, Australia

Location

St George Hospital; Medical Oncology

Sydney, New South Wales, 2217, Australia

Location

Redcliffe Hospital

Redcliffe, Queensland, 4020, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Ballarat Health Services

Ballarat, Victoria, 3350, Australia

Location

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Clinique André Renard; Pneumologie

Herstal, 4040, Belgium

Location

AZ Delta (Campus Rumbeke), Apotheek

Roeselare, 8800, Belgium

Location

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, 1303, Bulgaria

Location

Health & Care SPA

Santiago, 7500006, Chile

Location

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, 4800827, Chile

Location

Hospital Clinico Vina del Mar?

Viña del Mar, 2520612, Chile

Location

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, 100050, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Hunan Cancer Hospital

Changsha, 410013, China

Location

Changzhou First People's Hospital

Changzhou, 213003, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, 310003, China

Location

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

Location

Anhui Provincial Hospital; 2F,Tumor chemotherapy Department

Hefei, 230001, China

Location

Anhui Provincial Hospital; Respiratory Department

Hefei, 230088, China

Location

Qilu Hospital

Jinan, 250012, China

Location

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Nanjing, 210029, China

Location

Shanghai Chest Hospital

Shanghai, 200000, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

First Hospital of China Medical University

Shenyang, 110001, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 3000060, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430023, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Hopital Louis Pradel; Pneumologie

Bron, 69677, France

Location

Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Intercommunal; Service de Pneumologie

Créteil, 94010, France

Location

Polyclinique de Limoges - Site Chenieux; Oncologie Medicale

Limoges, 87039, France

Location

Hopital Nord AP-HM

Marseille, 13015, France

Location

Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse - Hopital Emile Muller

Mulhouse, 68070, France

Location

Hopital d'Instruction des Armees de Begin

Saint-Mandé, 94160, France

Location

Hopital d Instruction des Armees de Sainte Anne

Toulon, 83041, France

Location

Veszprem Megyei Tudogyogyintezet

Farkasgyepű, 8582, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

Location

Markusovszky Hospital

Szombathely, 9700, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, 2045, Hungary

Location

Mater Misecordiae University Hospital

Dublin, 7, Ireland

Location

St James's Hospital

Dublin, 8, Ireland

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Edith Wolfson Medical Center

Holon, 5822012, Israel

Location

Rabin Medical Center

Petach Tiqwa, 4941492, Israel

Location

Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

Lecce, Apulia, 73044, Italy

Location

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Apulia, 71013, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, Emilia-Romagna, 43126, Italy

Location

Ospedale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, 48100, Italy

Location

Istituto Nazionale Tumori Regina Elena

Rome, Lazio, 00144, Italy

Location

Azienda Policlinico Umberto I

Rome, Lazio, 00161, Italy

Location

Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

Orbassano (TO), Piedmont, 10043, Italy

Location

Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

Taormina, Sicily, 98039, Italy

Location

Ospedale San Luca - USL2 Lucca

Lucca, Tuscany, 55100, Italy

Location

National Hospital Organization Nagoya Medical Center

Aichi, 460-0001, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

National Hospital Organization Asahikawa Medical Center

Hokkaido, 070-8644, Japan

Location

National Hospital Organization Himeji Medical Center

Hyōgo, 670-8520, Japan

Location

Kanazawa University Hospital

Ishikawa, 920-8641, Japan

Location

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

Location

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Osaka, 569-8686, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo, 113-8677, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

NTT Medical Center Tokyo

Tokyo, 141-8625, Japan

Location

National Hospital Organization Yamaguchi - Ube Medical Center

Yamaguchi, 755-0241, Japan

Location

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, LV-1079, Latvia

Location

Panevezys Hospital

Panevezys, 35144, Lithuania

Location

Hospital Kuala Lumpur

Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586, Malaysia

Location

Advanced Medical and Dental Institute; Kompleks Klinikal

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, 6716 RP, Netherlands

Location

Ziekenhuis St. Jansdal

Harderwijk, 3844 DG, Netherlands

Location

Zuyderland Medisch Centrum - Sittard Geleen

Sittard-Geleen, 6162 BG, Netherlands

Location

Haga Ziekenhuis

The Hague, 2547 EX, Netherlands

Location

ETZ TweeSteden

Tilburg, 5042AD, Netherlands

Location

Hospital Nacional Cayetano Heredia

Lima, 31, Peru

Location

Hospital Beatriz Angelo

Loures, 2674-514, Portugal

Location

Unidade Local de Saude de Matosinhos SA

Matosinhos Municipality, 4454-509, Portugal

Location

Hospital CUF Porto; Servico de Imunoalergologia

Senhora Da Hora - Porto, 4460-188, Portugal

Location

Medisprof SRL

Cluj-Napoca, 400058, Romania

Location

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

Constanța, 900591, Romania

Location

Euroclinic Center of Oncology SRL

Iași, 700106, Romania

Location

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, Moscow Oblast, 454087, Russia

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, 150040, Russia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital General Universitario de Elche; Servicio de Oncologia

Elche, Alicante, 03203, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

ICO L'Hospitalet; Servicio de oncologia medica

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona, 08740, Spain

Location

Hospital de Mataro

Mataro, Cantabria, 08304, Spain

Location

Onkologikoa; Ensayos Clinicos

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Centro Oncologico de Galicia COG; Medical Oncology

A Coruña, LA Coruña, 15009, Spain

Location

Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia

El Palmar, Murcia, 30120, Spain

Location

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario de Navarra; Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario Nuestra Senora de Valme

Seville, Sevilla, 41014, Spain

Location

Hospital General Univ. de Alicante

Alicante, 03010, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

Barcelona, 08028, Spain

Location

C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia

Burgos, 09006, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica

Girona, 17007, Spain

Location

Hospital Lucus Augusti; Servicio de Oncologia

Lugo, 27003, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

HM Sanchinarro ? CIOCC

Madrid, 28050, Spain

Location

Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia

Málaga, 29010, Spain

Location

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, 46009, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Buddhist Dalin Tzuchi General Hospital

Dalin, Chiayi, 622, Taiwan

Location

E-DA Hospital; Chest

Kaohsiung City, 824, Taiwan

Location

Chi Mei Medical Center Liou Ying Campus

Liuying Township, 736, Taiwan

Location

National Taiwan Uni Hospital; Internal Medicine

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine

Location

Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept

Kyiv, Kharkiv Governorate, 02096, Ukraine

Location

MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology

Cherkasy, 18009, Ukraine

Location

Private Enterprise Private Manufacturing Company Acinus

Kirovograd, 25006, Ukraine

Location

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department

Sumy, 40022, Ukraine

Location

MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

Zaporizhzhya, 69040, Ukraine

Location

Bristol Haematology and Oncology centre

Bristol, BS2 8ED, United Kingdom

Location

Velindre Hospital

Cardiff, CF14 2TL, United Kingdom

Location

Gartnavel General Hospital; Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Raigmore Hospital

Inverness, IV2 3UV, United Kingdom

Location

St George?s Hospital

London, SW17 ORE, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Derriford Hospital; Plymouth Oncology Centre

Plymouth, PL6 8DH, United Kingdom

Location

Queen's Hospital

Romford, RM7 0AG, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumabCarboplatinCisplatinPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 15, 2016

Study Start

April 30, 2016

Primary Completion

July 18, 2019

Study Completion

December 13, 2022

Last Updated

November 21, 2023

Results First Posted

October 9, 2020

Record last verified: 2023-11

Locations