- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191786
A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy (IPSOS)
November 1, 2023 updated by: Hoffmann-La Roche
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable for Platinum-Containing Therapy
This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
453
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1125ABD
- Fundacion CENIT para la investigacion en Neurociencias
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Mar del Plata, Argentina, B7602CBM
- Hospital Privado de Comunidad
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Viedma, Argentina, R8500ACE
- Clinica Viedma S.A.
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Brussel, Belgium, 1090
- UZ Brussel
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Charleroi, Belgium, 6000
- Grand Hôpital de Charleroi Notre Dame
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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RS
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Porto Alegre, RS, Brazil, 90610-000
- Hospital Sao Lucas - PUCRS
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Porto Alegre, RS, Brazil, 91350-200
- Hospital Nossa Senhora da Conceicao
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SP
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Sao Paulo, SP, Brazil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Pleven, Bulgaria, 5800
- Umhat Dr Georgi Stranski; Clinic of Chemotherapy
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Plovdiv, Bulgaria, 4000
- Complex Oncology Center (COC)-Plovidiv
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
- Regional health authority A vitalite health network
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Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- Ottawa Hospital Research Institute
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Toronto, Ontario, Canada, M5G 1Z5
- Princess Margaret Cancer Center
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Beijing, China, 100142
- Beijing Cancer hospital
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Changsha, China, 410006
- Hu Nan Provincial Cancer Hospital
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Hangzhou City, China, 310009
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Hefei, China, 230001
- Anhui Provincial Hospital
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Shanghai, China, 200000
- Shanghai Chest Hospital
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Tianjin, China, 300060
- Tianjin Cancer Hospital
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Wuhan, China, 430023
- Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
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Bogota, Colombia
- Fundación Cardioinfantil
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Medellin, Colombia, 050022
- Fundacion Centro de Investigacion Clinica CIC
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Monteria, Colombia, 230002
- Oncomedica S.A.
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Pereira, Colombia, 600004
- Oncólogos de Occidente
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Olomouc, Czechia, 779 00
- Fakultni nemocnice Olomouc; Pneumologicka klinika
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Odense C, Denmark, 5000
- Odense Universitetshospital, Onkologisk Afdeling R
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Berlin, Germany, 13125
- Evang. Lungenklinik Berlin Klinik für Pneumologie
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Gauting, Germany, 82131
- Asklepios Klinik Gauting; Onkologisches Studienzentrum
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Großhansdorf, Germany, 22927
- LungenClinic Großhansdorf GmbH
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Halle, Germany, 06120
- Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
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Immenhausen, Germany, 34376
- Fachklinik für Lungenerkrankungen
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Marburg, Germany, 35032
- Klinikum der Philipps-Universität Marburg
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Regensburg, Germany, 93053
- Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
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Tübingen, Germany, 72076
- Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
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Delhi
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New Delhi, Delhi, India, 110076
- Indraprastha Apollo Hospitals
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New Delhi, Delhi, India, 110085
- Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
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New Delhi, Delhi, India, 110017
- Max Super Speciality Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380060
- HealthCare Global Cancer Centre; Medical Oncology
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Vadodara, Gujarat, India, 391760
- Kailash Cancer Hospital and Research Center
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Maharashtra
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Mahim(West), Maharashtra, India, 400016
- P.D. Hinduja Nat. Hospital & Med. Research Centre
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Mumbai, Maharashtra, India, 400012
- Tata Memorial Hospital; Dept of Medical Oncology
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Mumbai, Maharashtra, India, 400053
- Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz
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Nashik, Maharashtra, India, 422002
- HCG Manavata Cancer Centre
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Pune, Maharashtra, India, 411004
- Deenanath Mangeshkar Hospital & Research Centre
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Pune, Maharashtra, India, 411001
- Grant Medical Foundation, Ruby Hall Clinic
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Telangana
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Hyderabad, Telangana, India, 500034
- Indo-American Cancer Hospital & Research Center
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WEST Bengal
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Kolkata, WEST Bengal, India, 700160
- Tata Medical Center; Department of Medical Oncology
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Dublin, Ireland, 7
- Mater Misericordiae University Hospital - Institute for Cancer Research
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Limerick, Ireland
- University Hospital Limerick - Clinical Trials Department
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Emilia-Romagna
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Ravenna, Emilia-Romagna, Italy, 48100
- Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
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Lazio
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Roma, Lazio, Italy, 00152
- Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
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Lombardia
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Monza MI, Lombardia, Italy, 20900
- Azienda Ospedaliera San Gerardo di Monza
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Almaty, Kazakhstan, 050054
- Almaty Oncology Center
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Almaty, Kazakhstan, 050022
- Kazakh Scientific Research Institution Of Oncology and Radiology
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Luxembourg, Luxembourg, 1210
- Centre Hospitalier de Luxembourg
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Chihuahua, Mexico, 31000
- Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY
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Mexico CITY (federal District)
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Cdmx, Mexico CITY (federal District), Mexico, 03100
- Health Pharma Professional Research
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SAN LUIS Potosi
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San Luis Potosí, SAN LUIS Potosi, Mexico, 78209
- Oncologico Potosino
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Otwock, Poland, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
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Warszawa, Poland, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
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Coimbra, Portugal, 3000-075
- CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo
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Porto, Portugal, 4200-072
- IPO do Porto; Servico de Oncologia Medica
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Cluj Napoca, Romania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
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Floresti, Romania, 407280
- Centrul de Radioterapie AMETHYST
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Timi?oara, Romania, 300166
- Oncocenter Timisoara
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Nitra, Slovakia, 949 88
- Specializovana nemocnica sv. Svorada Zobor, n.o.; Oddelenie klinickej onkologie
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Trnava, Slovakia, 917 75
- Fakultna Nemocnica Trnava
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Barcelona, Spain, 08908
- Institut Catala d Oncologia Hospital Duran i Reynals
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Madrid, Spain, 28006
- Hospital Universitario de la Princesa; Servicio de Oncologia
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Madrid, Spain, 28040
- Hospital Universitario Clínico San Carlos; Servicio de Oncologia
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Malaga, Spain, 29010
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
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Murcia, Spain, 30008
- Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
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Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena; Servicio de Oncologia
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Valencia, Spain, 46015
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
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LA Coruña
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Santiago de Compostela, LA Coruña, Spain, 15706
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
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Vizcaya
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Bilbao, Vizcaya, Spain, 48903
- Hospital de Cruces; Servicio de Oncologia
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Bellinzona, Switzerland, 6500
- Ospedale Regionale di Bellinzona Medizin Onkologie
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Thun, Switzerland, 3600
- Spital STS AG - Spital Thun Medizin Onkologie; MEDIZINISCHE KLINIK
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Winterthur, Switzerland, 8401
- Kantonsspital Winterthur; Medizinische Onkologie
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Bebington, United Kingdom, CH63 4JY
- Clatterbridge Cancer Centre
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Birmingham, United Kingdom, B9 5SS
- Birmingham Heartlands Hospital
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Cornwall, United Kingdom, TR1 3LQ
- Royal Cornwall Hospital; Dept of Clinical Oncology
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Glasgow, United Kingdom, G42 9LF
- New Victoria Hospital
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London, United Kingdom, NW1 2PG
- University College London Hospitals NHS Foundation Trust - University College Hospital
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Manchester, United Kingdom, M2O 4BX
- Christie Hospital Nhs Trust; Medical Oncology
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York, United Kingdom, YO31 8HE
- YORK DISTRICT HOSPITAL; Haematology/Oncology Department
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Hanoi, Vietnam, 100000
- Bach Mai Hospital
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Hochiminh city, Vietnam, 700000
- Cho Ray Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the American Joint Committee on Cancer (AJCC) 7th edition
- No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected
- No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the AJCC 7th edition
- Life expectancy greater than or equal to (>/=) 8 weeks
- Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3). However, participants >= 70 years of age who have an ECOG PS of 0 or 1 may be included due to: a) substantial comorbidities; b) contraindication(s) for any platinum-doublet chemotherapy
- Representative formalin-fixed paraffin-embedded (FPPE) tumor tissue block obtained during course of disease (archival tissue) or at screening
- Participants with treated, asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: Measurable disease outside CNS; Only supratentorial and cerebellar metastases allowed; No ongoing requirement for corticosteroids as therapy for CNS disease; No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization; No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- Adequate hematologic and end organ function
- Female participants of childbearing potential randomized to the atezolizumab treatment arm agree to use protocol defined methods of contraception
Exclusion Criteria:
Cancer-Specific Exclusion Criteria:
- Participants younger than 70 years who have an ECOG performance status of 0 or 1
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation of the brain during screening and prior radiographic assessments
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled or symptomatic hyerpcalcemia (ionized calcium > 1.5 mmol/L or calcium >12 mg/dL or corrected serum calcium >ULN)
- History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (v4.0) Grade 3 or higher toxicities due to any prior therapy (example [e.g.], radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
- Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, 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 chemotherapy, radiotherapy, or chemoradiotherapy
General Medical Exclusion Criteria:
- History of autoimmune disease except autoimmune-related hypothyroidism and controlled Type I diabetes mellitus
- History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- Known positivity for human immunodeficiency virus (HIV)
- Known active hepatitis B or hepatitis C
- Active tuberculosis
- Severe infections within 4 weeks prior to randomization
- Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Major surgical procedure other than for diagnosis within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Participants with an illness or condition that may interfere with capacity or compliance with the study protocol, as per investigator's judgment
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to randomization
Exclusion Criteria Related to Atezolizumab:
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- Oral or IV antibiotic treatment
- Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to randomization
- Treatment with systemic corticosteroids or other immunosuppressive medications
- Participants not willing to stop treatment with traditional herbal medicines
Exclusion Criteria Related to Chemotherapy:
- Known sensitivity and contraindications to the 2 comparative chemotherapy agents (that is [i.e.] vinorelbine, oral or intravenous, and gemcitabine, intravenous)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Atezolizumab
Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
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Atezolizumab will be administered via IV infusion once every three weeks (QW3).
Other Names:
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Active Comparator: Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
Participants will receive single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice.
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Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.
Other Names:
Gemcitabine will be administered per relevant local guidelines and SmPC management.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival (OS)
Time Frame: From randomization up to death from any cause (up to approximately 55 months)
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Overall survival is defined as the time between the date of randomization and the date of death due to any cause.
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From randomization up to death from any cause (up to approximately 55 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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OS Rates at the 6, 12, 18, 24-Months Timepoints
Time Frame: 6, 12, 18 and 24 months
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OS rate at 6, 12, 18 and 24 months were estimated for each treatment arm.
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6, 12, 18 and 24 months
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Percentage of Participants With Objective Response Rate, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)
Time Frame: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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Objective response rate (ORR) is defined as a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR), as determined by the investigator with use of RECIST v1.1.
A minimum interval of 6 weeks (42 days) will be considered for Stable Disease (SD) to be assigned as best overall response, i.e. in the case the single response is SD, PR or CR, this single response must have been assessed no less than 6 weeks (at least 42 days) after start date of study treatment.
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From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1
Time Frame: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first.
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From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1
Time Frame: Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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DOR is defined as the time from the first tumor assessment that supports the participants' objective response (CR or PR, whichever is first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first, among patients who have a best overall response as CR or PR.
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Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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Percentage of Participants With At Lease One Adverse Event
Time Frame: From randomization up to approximately 55 months
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Percentage of participants with at least one adverse event.
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From randomization up to approximately 55 months
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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Time Frame: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)
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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 participants as clinically significant (Osoba et al. 1998).
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Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)
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Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Time Frame: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)
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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 participants as clinically significant (Osoba et al. 1998).
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Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)
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Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score
Time Frame: From baseline up to approximately 55 months
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TTD with use of the EORTC is defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores.
Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter.
A = 10-point change in the EORTC scale score is perceived by participants as clinically significant (Osoba et al. 1998).
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From baseline up to approximately 55 months
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Time to Deterioration in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
Time Frame: From baseline up to approximately 55 months
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TTD with use of the EORTC is defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores.
Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter.
A = 10-point change in the EORTC scale score is perceived by participants as clinically significant.
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From baseline up to approximately 55 months
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Overall Survival in Participants With PD-L1 Positive Status
Time Frame: From randomization up to death from any cause (up to approximately 55 months)
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Overall survival will be assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay.
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From randomization up to death from any cause (up to approximately 55 months)
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Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status
Time Frame: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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Investigator-assessed PFS according to RECIST v1.1 assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay.
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From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2017
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
October 25, 2023
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 19, 2017
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antibodies
- Antibodies, Monoclonal
- Vinorelbine
- Atezolizumab
- Gemcitabine
Other Study ID Numbers
- MO29872
- 2015-004105-16 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
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AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
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National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
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Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
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Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
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Hoffmann-La RocheCompletedTumorsFrance, United States, Denmark, Ireland, Italy, Turkey, United Kingdom, Canada, Brazil, Spain, Poland, Netherlands, Germany, Russian Federation, Austria, Finland, Norway, Switzerland
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Genentech, Inc.CompletedNon-Small Cell Lung CancerUnited States
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Genentech, Inc.CompletedNeoplasmsUnited States, Spain, Belgium, Korea, Republic of, Canada, Australia, France
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Hoffmann-La RocheCompletedCarcinoma, Non-Small-Cell LungChina, Korea, Republic of, Singapore, Thailand, Malaysia
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Genentech, Inc.Completed
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Hoffmann-La RocheCompletedColorectal CancerCanada, United States, Italy, Korea, Republic of, United Kingdom, Belgium, Russian Federation, Hong Kong, Spain, Australia, Poland
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Genentech, Inc.CompletedNon-Small Cell Lung CancerUnited States, France, United Kingdom, Belgium, Netherlands
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Hoffmann-La RocheCompletedSmall Cell Lung CarcinomaKorea, Republic of, United States, Hungary, Poland, China, France, Greece, Spain, United Kingdom, Brazil, Italy, Germany, Mexico, Australia, Serbia, Russian Federation, Japan, Austria, Chile, Czechia, Taiwan
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Hoffmann-La RocheCompletedRenal Cell CarcinomaKorea, Republic of, United States, France, Italy, United Kingdom, Canada, Australia, Brazil, Denmark, Spain, Turkey, Japan, Czechia, Singapore, Thailand, Taiwan, Russian Federation, Germany, Bosnia and Herzegovina, Poland, Mexico
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Hoffmann-La RocheCompletedRenal Cell CarcinomaUnited States, Spain, Czechia, United Kingdom, Romania, France, Italy, Germany, Poland