A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (TAIL)

A Phase III/IV, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (TAIL)

This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 619
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1118AAT
    • Hospital Aleman
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (Cori)
• Brazil
  • MG
    • Uberaba, MG, Brazil, 38082-049
      • Cetus Hospital Dia Oncologia
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
  • SP
    • Sao Paulo, SP, Brazil, 01327-001
      • Hospital Alemao Oswaldo Cruz
• China
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing City, China, 100006
    • Beijing Hospital
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Suzhou, China, 215006
    • First Affiliated Hospital of Soochow University
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Colombia
  • Bogota, D.C., Colombia, 111321
    • Organizacion Sanitas Internacional
• Costa Rica
  • San José, Costa Rica, 10103
    • Clinica CIMCA
• Denmark
  • Naestved, Denmark, 4700
    • Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
  • Vejle, Denmark, 7100
    • Vejle Sygehus; Onkologisk Afdeling
• Greece
  • Athens, Greece, 145 64
    • Agioi Anargyroi; 3Rd Dept. of Medical Oncology
  • Athens, Greece, 115 22
    • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • Athens, Greece, 115 27
    • Uoa Sotiria Hospital; Oncology
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Patras, Greece, 265 04
    • University Hospital of Patras Medical Oncology
  • Thessaloniki, Greece, 570 01
    • Diavalkaniko Hospital
• Guatemala
  • Guatemala, Guatemala, 01010
    • Oncomedica
• Italy
  • Basilicata
    • Rionero In Vulture (PZ), Basilicata, Italy, 85028
      • Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Campus Universitario S.Venuta; Centro Oncologico T.Campanella
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • Arcispedale Santa Maria Nuova; Medicina Nucleare
  • Lazio
    • Roma, Lazio, Italy, 00161
      • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
    • Roma, Lazio, Italy, 00184
      • AZ. Ospedaliera San Giovanni - Addolorata
  • Lombardia
    • Bergamo, Lombardia, Italy, 24125
      • Cliniche Gavazzeni S.p.A.; Dip. di Oncologia Pneumologica ed Urologica
    • Brescia, Lombardia, Italy, 25123
      • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
    • Milano, Lombardia, Italy, 20162
      • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
  • Marche
    • Ancona, Marche, Italy, 60121
      • Ospedali Riuniti Di Ancona; Oncology
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
      • Ospedale Oncologico A.Businco; Div. Oncologia Medica II
  • Sicilia
    • Catania, Sicilia, Italy, 95126
      • Ospedale Cannizzaro, Oncologia
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
    • Pisa, Toscana, Italy, 56124
      • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
  • Valle D?Aosta
    • Aosta, Valle D?Aosta, Italy, 11100
      • Ospedale Regionale Umberto Parini; S.C. Oncologia
  • Veneto
    • Treviso, Veneto, Italy, 31100
      • ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso
• Latvia
  • R?ga, Latvia, LV-1002
    • Pauls Stradins Clinical University hospital
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital Latvian Oncology Centre
• Lebanon
  • Beirut, Lebanon, 2063 1111
    • Hotel Dieu de France; Oncology
  • El-Metn, Lebanon, 2241
    • Bellevue Medical Center
• Malaysia
  • FED. Territory OF Kuala Lumpur
    • Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre; Clinical Oncology Unit,
    • Putrajaya, FED. Territory OF Kuala Lumpur, Malaysia, 62250
      • Institute Kanser Negara (IKN)
  • Penang
    • Georgetown, Penang, Malaysia, 10450
      • Hospital Pulau Pinang; Jabatan Respiratori
    • Pulau Pinang, Penang, Malaysia, 11200
      • Mount Miriam Cancer Hospital
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Hospital Umum Sarawak; Oncology and Radiotherapy
• Mexico
  • Mexico CITY (federal District)
    • Cdmx, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
    • Mexico D.F., Mexico CITY (federal District), Mexico, 04700
      • Centro Oncologico Internacional
  • Oaxaca
    • Oaxaca de Juárez, Oaxaca, Mexico, 68000
      • Oaxaca Site Management Organization
  • SAN LUIS Potosi
    • San Luis Potosí, SAN LUIS Potosi, Mexico, 78209
      • Oncologico Potosino
  • Yucatan
    • Mérida, Yucatan, Mexico, 97125
      • Investigacion Clinica Merida
• Morocco
  • Casablanca, Morocco, 20100
    • Clinique le Littoral
  • FES, Morocco, 30000
    • Centre Hospitalier Universitaire Hassan II
  • Rabat, Morocco, 6213
    • Institut National D'oncologie Sidi Med Benabdellah
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum
  • Arnhem, Netherlands, 6815 AD
    • Ziekenhuis Rijnstate
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis; Afdeling Longziekten
  • Hilversum, Netherlands, 1213 HX
    • Tergooiziekenhuizen, loc. Hilversum
  • Nijmegen, Netherlands, 6500 HB
    • UMC Radboud Nijmegen
  • Zwolle, Netherlands, 8025 AB
    • Isala
• Panama
  • Panama, Panama, 0832
    • The Panama Clinic
• Peru
  • Arequipa, Peru, 5154
    • Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
  • Lima, Peru, 15036
    • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
• Philippines
  • Las Pinas, Philippines, 1740
    • University of Perpetual Help System DALTA Medical Center
  • Pasig, Philippines, 1605
    • The Medical City Hospital; Cancer Research Room
  • Quezon City, Philippines, 1100
    • East Avenue Medical Center
• Poland
  • Gliwice, Poland, 44-101
    • Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Poznan, Poland, 60-569
    • Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
  • Warszawa, Poland, 02-781
    • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
• Slovenia
  • Golnik, Slovenia, 4204
    • University Clinic Golnik
• Spain
  • Alicante, Spain, 3010
    • Hospital General Univ. de Alicante; Servicio de Oncologia
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Oncologia
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia; Servicio de oncologia
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Castellon
    • Castellon de La Plana, Castellon, Spain, 12002
      • Hospital Provincial de Castellon; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20080
      • Hospital de Donostia; Servicio de Oncologia Medica
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases; Servicio de Oncologia
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Oncologia
    • San Sebastian de Los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofia; Servico de Oncologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra; Servicio de Oncologia
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Oncologia
• Sweden
  • Goeteborg, Sweden, 41345
    • Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital; Department of Oncology
• United Arab Emirates
  • Al Ain, United Arab Emirates, 15258
    • Tawam Hospital
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital ; Department of Respiratory Medicine (Rm 30)
  • Hull, United Kingdom, HU16 5JQ
    • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
  • Larbert, United Kingdom, FK5 4QE
    • Forth Valley Royal Hospital ; Oncology Department
  • London, United Kingdom, SW10 9TH
    • Chelsea & Westminster Hospital
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Cancer Centre
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross 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 documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy, after anti-PD-1 as monotherapy, or after TKI therapy). Participants with a previously detected sensitizing epidermal growth factor receptor (EGFR) mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusion oncogene must have received targeted therapy (TKI) followed by at least one line of standard systemic chemotherapy prior to receiving atezolizumab. Overall, participants should not have received more than two lines of standard systemic chemotherapy. Participants who have discontinued first-line or second-line therapy due to intolerance are also eligible
• The last dose of prior systemic anticancer therapy or targeted therapy must have been administered more than or equal to (≥) 21 days prior to randomization.
• The last dose of prior anti-PD-1 therapy must have been administered. Nivolumab must have been discontinued >= 14 days and pembrolizumab >= 21 days prior to study treatment initiation, providing that these treatments were not administered in a clinical trial setting.
• Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
• Participants with asymptomatic central nervous system (CNS) metastases (treated or untreated), as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic evaluation, are eligible
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Life expectancy ≥ 12 weeks
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) 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
• Participants must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy

Exclusion Criteria:

• Symptomatic CNS metastases
• 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 ≥ 2 weeks prior to study treatment initiation
• Leptomeningeal disease
• Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
• Pregnant or lactating, or intending to become pregnant during the study
• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
• Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
• Significant renal disorder requiring dialysis or indication for renal transplant
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
• Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
• Inability to understand the local language(s) for which the EORTC QLQ-LC13 and EQ-5D-5L questionnaires are available
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
• Active tuberculosis
• Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation
• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies other than anti-PD-1 therapy, including anti-programmed death-ligand 1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
• Specifically for participants without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study treatment initiation, or anticipated requirement for systemic immunosuppressive medications during the trial. For participants with CNS metastases, use of prednisone at a stable dose (or dose equivalent) of <= 20 mg/day is acceptable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab; Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).	Drug: Atezolizumab; Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).; Other Names: Tecentriq; RO5541267

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.	Baseline up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Alive 2 Years After Initiation of Treatment	The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment.	Baseline up to Year 2
Overall Survival (OS)	OS was defined as the time (in months) from initiation of study treatment to death from any cause.	Baseline up to death (up to 4 years)
Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)	PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1.	Baseline up to disease progression or death whichever occurs first (up to 4 years)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item	The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a Visual Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.	Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Self-Care Item	The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.	Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Usual Activities Item	The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.	Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Pain/Discomfort Item	The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.	Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Anxiety/Depression Item	The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.	Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - VAS Scores	The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline.	Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)	The EORTC QLQ-LC13 consisted of 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A >=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline.	Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)
Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST	PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to modified RECIST.	Baseline up to disease progression or death whichever occurs first (up to 4 years)
Percentage of Participants Alive 3 Years After Initiation of Treatment	The OS rate at 3 years, was defined as the percentage of participants remaining alive 3 years after initiation of study treatment.	Baseline up to Year 3
Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1	Objective response rate (ORR), according to RECIST v1.1, was defined as the percentage of participants with a confirmed best overall response (BOR), either complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1.	Baseline up to disease progression or death whichever occurs first (up to 4 years)
Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST	The investigator-assessed ORR was defined as the proportion of participants whose confirmed BOR is either a PR or CR per modified RECIST.	Baseline up to disease progression or death whichever occurs first (up to 4 years)
Duration of Response as Assessed by the Investigator According to RECIST v.1.1	DOR was defined as the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first, among participants who had a best overall response as CR or PR.	From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Duration of Response as Assessed by the Investigator According to Modified RECIST	DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurred first.	From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Ardizzoni A, Azevedo S, Rubio-Viqueira B, Rodriguez-Abreu D, Alatorre-Alexander J, Smit HJM, Yu J, Syrigos K, Trunzer K, Patel H, Tolson J, Cardona A, Perez-Moreno PD, Newsom-Davis T. Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer. J Immunother Cancer. 2021 Mar;9(3):e001865. doi: 10.1136/jitc-2020-001865.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 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; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Atezolizumab
• Other Study ID Numbers: MO39171; 2017-001409-34 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No