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)

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Vinorelbine; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundación Cenit para la Investigación en Neurociencias
  • Mar del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Viedma, Argentina, R8500ACE
    • Clinica Viedma S.A.
• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Charleroi, Belgium, 6000
    • Grand Hôpital de Charleroi Notre Dame
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
    • Porto Alegre, RS, Brazil, 90040-373
      • Hospital Nossa Senhora da Conceicao
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Umhat Dr Georgi Stranski; Clinic of Chemotherapy
  • Plovdiv, Bulgaria, 4000
    • Complex Oncology Center (COC)-Plovidiv
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BCCA-Vancouver Cancer Centre
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Regional health authority A vitalite health network
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changsha, China, 410006
    • Hu Nan Provincial Cancer Hospital
  • Hangzhou City, China, 310009
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Shanghai, China, 200000
    • Shanghai Chest Hospital
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Wuhan, China, 430023
    • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
• Colombia
  • Bogota, Colombia
    • Fundacion Cardioinfantil
  • Medellin, Colombia, 050022
    • Fundacion Centro de Investigacion Clinica CIC
  • Monteria, Colombia, 230002
    • Oncomedica S.A.
  • Pereira, Colombia, 600004
    • Oncólogos de Occidente
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc; Pneumologicka klinika
• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
• Germany
  • Berlin, Germany, 13125
    • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Gauting, Germany, 82131
    • Asklepios Klinik Gauting; Onkologisches Studienzentrum
  • Großhansdorf, Germany, 22927
    • LungenClinic Großhansdorf GmbH; Klinische Forschung
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Marburg, Germany, 35032
    • Klinikum der Philipps-Universität Marburg
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
• India
  • Delhi
    • New Delhi, Delhi, India, 110076
      • Indraprastha Apollo Hospitals
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
    • New Delhi, Delhi, India, 110017
      • Max Super Speciality Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • HealthCare Global Cancer Centre; Medical Oncology
    • Vadodara, Gujarat, India, 391760
      • Kailash Cancer Hospital and Research Center
  • Maharashtra
    • Mahim(West), Maharashtra, India, 400016
      • P.D. Hinduja Nat. Hospital & Med. Research Centre
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial Hospital; Dept of Medical Oncology
    • Mumbai, Maharashtra, India, 400053
      • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz
    • Nashik, Maharashtra, India, 422002
      • HCG Manavata Cancer Centre
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital & Research Centre
    • Pune, Maharashtra, India, 411001
      • Grant Medical Foundation, Ruby Hall Clinic
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Indo-American Cancer Hospital & Research Center
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700160
      • Tata Medical Center; Department of Medical Oncology
• Ireland
  • Dublin, Ireland, 7
    • Mater Misericordiae University Hospital - Institute for Cancer Research
  • Limerick, Ireland
    • University Hospital Limerick - Clinical Trials Department
• Italy
  • Emilia-Romagna
    • Ravenna, Emilia-Romagna, Italy, 48100
      • Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
  • Lombardia
    • Monza MI, Lombardia, Italy, 20900
      • Azienda Ospedaliera San Gerardo di Monza
• Kazakhstan
  • Almaty, Kazakhstan, 050054
    • Almaty Oncology Center
  • Almaty, Kazakhstan, 050022
    • Kazakh Scientific Research Institution Of Oncology and Radiology
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg
• Mexico
  • Chihuahua, Mexico, 31000
    • Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY
  • Mexico CITY (federal District)
    • Cdmx, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
  • SAN LUIS Potosi
    • San Luis Potosí, SAN LUIS Potosi, Mexico, 78209
      • Oncologico Potosino
• Poland
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Warszawa, Poland, 02-781
    • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
• Portugal
  • Coimbra, Portugal, 3000-075
    • CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Romania
  • Cluj Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
  • Floresti, Romania, 407280
    • Centrul de Radioterapie Amethyst
  • Timi?oara, Romania, 300166
    • Oncocenter Timisoara
• Slovakia
  • Nitra, Slovakia, 949 88
    • Specializovana nemocnica sv. Svorada Zobor, n.o.; Oddelenie klinickej onkologie
  • Trnava, Slovakia, 917 75
    • Fakultna nemocnica Trnava
• Spain
  • Barcelona, Spain, 08908
    • Institut Catala d Oncologia Hospital Duran i Reynals
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Murcia, Spain, 30008
    • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Oncologia
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Ospedale Regionale di Bellinzona Medizin Onkologie
  • Thun, Switzerland, 3600
    • Spital STS AG - Spital Thun Medizin Onkologie; MEDIZINISCHE KLINIK
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur; Medizinische Onkologie
• United Kingdom
  • Bebington, United Kingdom, CH63 4JY
    • Clatterbridge Cancer Centre
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Cornwall, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital; Dept of Clinical Oncology
  • Glasgow, United Kingdom, G42 9LF
    • New Victoria Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust - University College Hospital
  • Manchester, United Kingdom, M2O 4BX
    • Christie Hospital Nhs Trust; Medical Oncology
  • York, United Kingdom, YO31 8HE
    • YORK DISTRICT HOSPITAL; Haematology/Oncology Department
• Vietnam
  • Hanoi, Vietnam, 100000
    • Bach Mai hospital
  • Hochiminh city, Vietnam, 700000
    • Cho Ray Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Atezolizumab will be administered via IV infusion once every three weeks (QW3).; Other Names: MPDL3280A
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.	Drug: Vinorelbine; Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.; Other Names: Navelbine®; Drug: Gemcitabine; Gemcitabine will be administered per relevant local guidelines and SmPC management.; Other Names: Gemzar®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as the time between the date of randomization and the date of death due to any cause. Kaplan-Meier (KM) estimates were used to calculate median.	From randomization up to death from any cause (up to approximately 55 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS Rates at the 6, 12, 18, 24-Months Timepoints	OS was defined as the time between the date of randomization and the date of death due to any cause. OS rate at 6, 12, 18 and 24 months were estimated for each treatment arm using Kaplan Meier methodology. Percentages were rounded off to the nearest decimal point.	6, 12, 18 and 24 months
Percentage of Participants With Objective Response, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)	Objective response rate (ORR)=best overall response (BOR) of either complete response (CR)/partial response (PR), as determined by investigator with use of RECIST v1.1. CR= disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A minimum interval of 6 weeks (42 days) was considered for stable disease (SD) to be assigned as BOR, i.e. in 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. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the diameters while in the study. Percentages were rounded off to the nearest decimal point.	From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1	PFS was 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. Progressive disease (PD) was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. KM estimates were used to calculate median.	From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)
Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1	DOR was 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 participants who have a best overall response as CR or PR. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. KM estimates were used to calculate median.	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)
Percentage of Participants With At Least One Adverse Event (AE)	An AE was any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).	Baseline up to 90 days after last dose of atezolizumab (approximately 62 months)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score	EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of patient functioning (physical, emotional, role, cognitive, and social), 3 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). It was scored according to EORTC scoring manual (Fayers et al. 2001). All EORTC scales & 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/healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score was perceived by participants as clinically significant (Osoba et al. 1998). A positive change from baseline=improvement & negative change from baseline indicated worsening.	Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) 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 was 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 was perceived by participants as clinically significant (Osoba et al. 1998). A positive change from baseline indicates improvement and negative change from baseline indicated worsening.	Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score	TTD with use of the EORTC was 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 was 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 was perceived by participants as clinically significant (Osoba et al. 1998).	From baseline up to approximately 55 months
TTD in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score	TTD with use of the EORTC was 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 was 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 was perceived by participants as clinically significant.	From baseline up to approximately 55 months
OS in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Status	OS was defined as the time between the date of randomization and the date of death due to any cause. OS was assessed in participants whose tumors express PD-L1 protein (i.e., tumor cell (TC) ≥1%) as measured by PD-L1 SP263 immunohistochemistry (IHC) assay. KM estimates were used to calculate the median.	From randomization up to death from any cause (up to approximately 55 months)
PFS as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status	PFS was 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. PD was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. Investigator-assessed PFS was assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. KM estimates were used to calculate the median.	From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

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): October 23, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine; Atezolizumab; Gemcitabine; Antibodies; Antibodies, Monoclonal
• 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