AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT02657434

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)

A Phase 3 study testing Atezolizumab, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 183 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Atezolizumab, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
578 participants
Where
183 sitesin 27 countries
Study dates
30 Apr 2016to 13 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper limit of normal)
  • Malignancies other than NSCLC within 5 years prior to randomization
  • Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not eligible are excluded)
  • General Medical Exclusions:
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of certain autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
  • All participants will be tested for human immunodeficiency virus (HIV) prior to the inclusion into the study and HIV-positive participants will be excluded from the clinical study
  • Severe infections within 4 weeks prior to randomization
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
  • Prior treatment with EGFR inhibitors or ALK inhibitors
  • Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to initiation of study treatment
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
  • Treatment with systemic immunosuppressive medications
  • History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
  • Participants with hearing impairment (cisplatin)
  • Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)
  • Creatinine clearance (CRCL) <60 milliliters/minute (mL/min) for cisplatin or <45 mL/min for carboplatin

Trial locations and contacts

183 sites in 27 countries.

183 sites in 27 countries

United States26 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-0934

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Swedish Cancer Institute

    Cary, North Carolina, 27513

  • Virginia Cancer Specialists (Fairfax) - USOR

    Fairfax, Virginia, 22031

  • Fort Wayne Med Oncology & Hematology Inc

    Fort Wayne, Indiana, 46845

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Goshen Health System

    Goshen, Indiana, 46526

  • CHI Health St. Francis

    Grand Island, Nebraska, 68803

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54311

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Oncology Consultants PA

    Houston, Texas, 77030

  • University of Kentucky; Markey Cancer Center

    Lexington, Kentucky, 40536

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Orlando Health Inc.

    Orlando, Florida, 32806

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • University of Washington

    Seattle, Washington, 98195

  • St. Joseph Heritage Healthcare

    Sebastopol, California, 95472

  • Stamford Hospital; BCC, MOHR

    Stamford, Connecticut, 06904

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • HealthCare Research Network II, LLC - PPDS

    Tinley Park, Illinois, 60487

Other trials in United States

Spain24 sites

  • Centro Oncologico de Galicia COG; Medical Oncology

    A Coruña, LA Coruña, 15009

  • Hospital General Univ. de Alicante

    Alicante, 03010

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

    Barcelona, 08028

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

    Burgos, 09006

  • Onkologikoa; Ensayos Clinicos

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia

    El Palmar, Murcia, 30120

  • Hospital General Universitario de Elche; Servicio de Oncologia

    Elche, Alicante, 03203

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

    Girona, 17007

  • ICO L'Hospitalet; Servicio de oncologia medica

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Lucus Augusti; Servicio de Oncologia

    Lugo, 27003

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • HM Sanchinarro ? CIOCC

    Madrid, 28050

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

    Málaga, 29010

  • Hospital de Mataro

    Mataro, Cantabria, 08304

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Sant Andreu de la Barca, Barcelona, 08740

  • Complejo Hospitalario Nuestra Senora de Valme

    Seville, Sevilla, 41014

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Japan20 sites

  • National Hospital Organization Nagoya Medical Center

    Aichi, 460-0001

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Hospital Organization Asahikawa Medical Center

    Hokkaido, 070-8644

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Osaka University Hospital

    Osaka, 565-0871

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686

  • Saga University Hospital

    Saga, 849-8501

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • NTT Medical Center Tokyo

    Tokyo, 141-8625

  • National Hospital Organization Yamaguchi - Ube Medical Center

    Yamaguchi, 755-0241

Other trials in Japan

China19 sites

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050

  • Beijing Cancer Hospital

    Beijing, 100142

  • Hunan Cancer Hospital

    Changsha, 410013

  • Changzhou First People's Hospital

    Changzhou, 213003

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • The First Affiliated Hospital of Medical School of Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

  • Anhui Provincial Hospital; 2F,Tumor chemotherapy Department

    Hefei, 230001

  • Anhui Provincial Hospital; Respiratory Department

    Hefei, 230088

  • Qilu Hospital

    Jinan, 250012

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

    Nanjing, 210029

  • Shanghai Chest Hospital

    Shanghai, 200000

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • First Hospital of China Medical University

    Shenyang, 110001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 3000060

  • Tianjin Medical University General Hospital

    Tianjin, 300052

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

    Wuhan, 430023

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

Other trials in China

France10 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • Hopital Louis Pradel; Pneumologie

    Bron, 69677

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

    Clermont-Ferrand, 63003

  • Centre Hospitalier Intercommunal; Service de Pneumologie

    Créteil, 94010

  • Polyclinique de Limoges - Site Chenieux; Oncologie Medicale

    Limoges, 87039

  • Hopital Nord AP-HM

    Marseille, 13015

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

    Montpellier, 34298

  • Centre Hospitalier de Mulhouse - Hopital Emile Muller

    Mulhouse, 68070

  • Hopital d'Instruction des Armees de Begin

    Saint-Mandé, 94160

  • Hopital d Instruction des Armees de Sainte Anne

    Toulon, 83041

Other trials in France

United Kingdom10 sites

  • Bristol Haematology and Oncology centre

    Bristol, BS2 8ED

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Gartnavel General Hospital; Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Raigmore Hospital

    Inverness, IV2 3UV

  • St George?s Hospital

    London, SW17 ORE

  • Charing Cross Hospital

    London, W6 8RF

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Derriford Hospital; Plymouth Oncology Centre

    Plymouth, PL6 8DH

  • Queen's Hospital

    Romford, RM7 0AG

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

Other trials in United Kingdom

Australia9 sites

  • Ballarat Health Services

    Ballarat, Victoria, 3350

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Barwon Health

    Geelong, Victoria, 3220

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Redcliffe Hospital

    Redcliffe, Queensland, 4020

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Sydney Adventist Hospital; Clinical Trial Unit

    Sydney, New South Wales, 2076

  • St George Hospital; Medical Oncology

    Sydney, New South Wales, 2217

Other trials in Australia

Italy9 sites

  • Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

    Lecce, Apulia, 73044

  • Ospedale San Luca - USL2 Lucca

    Lucca, Tuscany, 55100

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

    Orbassano (TO), Piedmont, 10043

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Emilia-Romagna, 43126

  • Ospedale Santa Maria Delle Croci

    Ravenna, Emilia-Romagna, 48100

  • Istituto Nazionale Tumori Regina Elena

    Rome, Lazio, 00144

  • Azienda Policlinico Umberto I

    Rome, Lazio, 00161

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Apulia, 71013

  • Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

    Taormina, Sicily, 98039

Other trials in Italy

Netherlands6 sites

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Ziekenhuis St. Jansdal

    Harderwijk, 3844 DG

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

  • Haga Ziekenhuis

    The Hague, 2547 EX

  • ETZ TweeSteden

    Tilburg, 5042AD

Other trials in Netherlands

Taiwan6 sites

  • Buddhist Dalin Tzuchi General Hospital

    Dalin, Chiayi, 622

  • E-DA Hospital; Chest

    Kaohsiung City, 824

  • Chi Mei Medical Center Liou Ying Campus

    Liuying Township, 736

  • National Taiwan Uni Hospital; Internal Medicine

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Ukraine6 sites

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

    Cherkasy, 18009

  • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

    Dnipropetrovsk, Katerynoslav Governorate, 49102

  • Private Enterprise Private Manufacturing Company Acinus

    Kirovograd, 25006

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

    Kyiv, Kharkiv Governorate, 02096

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department

    Sumy, 40022

  • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

    Zaporizhzhya, 69040

Other trials in Ukraine

Hungary5 sites

  • Veszprem Megyei Tudogyogyintezet

    Farkasgyepű, 8582

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Markusovszky Hospital

    Szombathely, 9700

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Argentina3 sites

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, 00001428

  • Fundacion Clinica Colombo

    Córdoba, X5002AOQ

  • Clinica Viedma S.A.

    Viedma, R8500ACE

Other trials in Argentina

Belgium3 sites

  • AZ Maria Middelares

    Ghent, 9000

  • Clinique André Renard; Pneumologie

    Herstal, 4040

  • AZ Delta (Campus Rumbeke), Apotheek

    Roeselare, 8800

Other trials in Belgium

Chile3 sites

  • Health & Care SPA

    Santiago, 7500006

  • Sociedad de Investigaciones Medicas Ltda (SIM)

    Temuco, 4800827

  • Hospital Clinico Vina del Mar?

    Viña del Mar, 2520612

Other trials in Chile

Israel3 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Rabin Medical Center

    Petach Tiqwa, 4941492

Other trials in Israel

Portugal3 sites

  • Hospital Beatriz Angelo

    Loures, 2674-514

  • Unidade Local de Saude de Matosinhos SA

    Matosinhos Municipality, 4454-509

  • Hospital CUF Porto; Servico de Imunoalergologia

    Senhora Da Hora - Porto, 4460-188

Other trials in Portugal

Romania3 sites

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

    Constanța, 900591

  • Euroclinic Center of Oncology SRL

    Iași, 700106

Other trials in Romania

Russia3 sites

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, Moscow Oblast, 454087

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Ireland2 sites

  • Mater Misecordiae University Hospital

    Dublin, 7

  • St James's Hospital

    Dublin, 8

Other trials in Ireland

Malaysia2 sites

  • Advanced Medical and Dental Institute; Kompleks Klinikal

    Kepala Batas, Pulau Pinang, 13200

  • Hospital Kuala Lumpur

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586

Other trials in Malaysia

Austria1 site

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Bulgaria1 site

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, 1303

Other trials in Bulgaria

Latvia1 site

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Lithuania1 site

  • Panevezys Hospital

    Panevezys, 35144

Other trials in Lithuania

Peru1 site

  • Hospital Nacional Cayetano Heredia

    Lima, 31

Other trials in Peru

About this study

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

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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called MPDL3280A, TECENTRIQ

    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.

  • CarboplatinDrug

    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.

  • CisplatinDrug

    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.

  • PemetrexedDrug

    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.

Study groups in NCT02657434
Study groupRoleWhat they receive
Arm A (Atezolizumab + Carboplatin or Cisplatin + PemetrexedExperimentalParticipants 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.
Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed
Arm B (Carboplatin or Cisplatin + Pemetrexed)Active comparatorParticipants 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.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Randomization up to approximately 39 months

  2. Overall Survival (OS)

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

    Measured: Randomization up to approximately 39 months

Secondary outcomes (13)

  1. 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.

    Measured: Year 1

  2. 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.

    Measured: Year 2

  3. 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.

    Measured: Randomization up to approximately 25 months

  4. 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.

    Measured: Randomization up to approximately 25 months

  5. 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).

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

  6. 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).

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

  7. 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.

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

  8. Minimum Observed Serum Atezolizumab Concentration (Cmin)

    Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)

    Measured: 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)

  9. Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)

    Measured: Day 1 of Cycle 1 (Cycle length=21 days)

  10. Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)

    Measured: 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)

  11. Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)

    Measured: 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)

  12. Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)

    Measured: 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)

  13. 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)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2016 (estimated)
  2. Study start30 Apr 2016
  3. Primary completion18 Jul 2019
  4. Study completion13 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
578 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657434
Sponsor's protocol ID
GO29438
Other IDs
2015-003605-42, 2015
Status last verified
Nov 2023
First submitted
14 Jan 2016
Last updated
21 Nov 2023

Publications

  • 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.

    PubMed 36795388

  • 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.

    PubMed 36052772

  • 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.

    PubMed 35511917

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 183 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, Spain, Japan, China, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Randomization up to approximately 39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02657434, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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