AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 4TAILNCT03285763

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)

A Phase 4 study testing Atezolizumab in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 111 sites in 24 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a 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]… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
619 participants
Where
111 sitesin 24 countries
Study dates
25 Oct 2017to 7 Apr 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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)
Show all 21Show fewer
  • 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.

Trial locations and contacts

111 sites in 24 countries.

111 sites in 24 countries

Spain27 sites

  • Hospital General Univ. de Alicante; Servicio de Oncologia

    Alicante, 3010

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041

  • Hospital Provincial de Castellon; Servicio de Oncologia

    Castellon, Castellon, 12002

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital de Donostia; Servicio de Oncologia Medica

    Donostia / San Sebastian, Guipuzcoa, 20080

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

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

    Granada, 18014

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    Jaén, 23007

  • Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital Lucus Augusti; Servicio de Oncologia

    Lugo, 27003

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Majadahonda, Madrid, 28222

  • Hospital Univ. Central de Asturias; Servicio de Oncologia

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07014

  • Complejo Hospitalario de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Hospital Quiron de Madrid; Servicio de Oncologia

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Infanta Sofia; Servico de Oncologia

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 46014

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

    Zaragoza, 50009

Other trials in Spain

Italy16 sites

  • Ospedali Riuniti Di Ancona; Oncology

    Ancona, The Marches, 60121

  • Ospedale Regionale Umberto Parini; S.C. Oncologia

    Aosta, Aosta Valley, 11100

  • Cliniche Gavazzeni S.p.A.; Dip. di Oncologia Pneumologica ed Urologica

    Bergamo, Lombardy, 24125

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

    Brescia, Lombardy, 25123

  • Ospedale Oncologico A.Businco; Div. Oncologia Medica II

    Cagliari, Sardinia, 09121

  • Ospedale Cannizzaro, Oncologia

    Catania, Sicily, 95126

  • Campus Universitario S.Venuta; Centro Oncologico T.Campanella

    Catanzaro, Calabria, 88100

  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

    Florence, Tuscany, 50134

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

    Pisa, Tuscany, 56124

  • Arcispedale Santa Maria Nuova; Medicina Nucleare

    Reggio Emilia, Emilia-Romagna, 42100

  • Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica

    Rionero in Vulture (PZ), Basilicate, 85028

  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

    Rome, Lazio, 00161

  • AZ. Ospedaliera San Giovanni - Addolorata

    Rome, Lazio, 00184

  • ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso

    Treviso, Veneto, 31100

Other trials in Italy

United Kingdom7 sites

  • Royal United Hospital

    Bath, BA1 3NG

  • Birmingham Heartlands Hospital ; Department of Respiratory Medicine (Rm 30)

    Birmingham, B9 5SS

  • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

    Hull, HU16 5JQ

  • Forth Valley Royal Hospital ; Oncology Department

    Larbert, FK5 4QE

  • Chelsea & Westminster Hospital

    London, SW10 9TH

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Greece6 sites

  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

    Athens, 115 22

  • Uoa Sotiria Hospital; Oncology

    Athens, 115 27

  • Agioi Anargyroi; 3Rd Dept. of Medical Oncology

    Athens, 145 64

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Diavalkaniko Hospital

    Thessaloniki, 570 01

Other trials in Greece

Netherlands6 sites

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • Amphia Ziekenhuis; Afdeling Longziekten

    Breda, 4818 CK

  • Tergooiziekenhuizen, loc. Hilversum

    Hilversum, 1213 HX

  • UMC Radboud Nijmegen

    Nijmegen, 6500 HB

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

China5 sites

  • Beijing Hospital

    Beijing, 100006

  • Chinese PLA General Hospital

    Beijing, 100853

  • Shandong Cancer Hospital

    Jinan, 250117

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Malaysia5 sites

  • Hospital Pulau Pinang; Jabatan Respiratori

    George Town, Pulau Pinang, 10450

  • University Malaya Medical Centre; Clinical Oncology Unit,

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100

  • Hospital Umum Sarawak; Oncology and Radiotherapy

    Kuching, Sarawak, 93586

  • Mount Miriam Cancer Hospital

    Pulau Pinang, Pulau Pinang, 11200

  • Institute Kanser Negara (IKN)

    Putrajaya, FED. Territory of Kuala Lumpur, 62250

Other trials in Malaysia

Mexico5 sites

  • Investigacion Clinica Merida

    Mérida, Yucatán, 97125

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Centro Oncologico Internacional

    Mexico City, Mexico CITY (federal District), 04700

  • Oaxaca Site Management Organization

    Oaxaca City, Oaxaca, 68000

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78209

Other trials in Mexico

Poland5 sites

  • Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii

    Gliwice, 44-101

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

    Otwock, 05-400

  • Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

    Poznan, 60-569

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

    Warsaw, 02-781

Other trials in Poland

Brazil3 sites

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

  • CETUS Hospital Dia Oncologia

    Uberaba, Minas Gerais, 38082-049

Other trials in Brazil

Denmark3 sites

  • Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

    Næstved, 4700

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

  • Vejle Sygehus; Onkologisk Afdeling

    Vejle, 7100

Other trials in Denmark

Morocco3 sites

  • Clinique le Littoral

    Casablanca, 20100

  • Centre Hospitalier Universitaire Hassan II

    Fes, 30000

  • Institut National D'oncologie Sidi Med Benabdellah

    Rabat, 6213

Other trials in Morocco

Philippines3 sites

  • University of Perpetual Help System DALTA Medical Center

    Las Piñas, 1740

  • The Medical City Hospital; Cancer Research Room

    Pasig, 1605

  • East Avenue Medical Center

    Quezon City, 1100

Other trials in Philippines

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken

    Gothenburg, 41345

  • Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

    Stockholm, 171 76

  • Uppsala University Hospital; Department of Oncology

    Uppsala, 751 85

Other trials in Sweden

Argentina2 sites

  • Hospital Aleman

    Caba, C1118AAT

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

Other trials in Argentina

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Lebanon2 sites

  • Hotel Dieu de France; Oncology

    Beirut, 2063 1111

  • Bellevue Medical Center

    El-Metn, 2241

Other trials in Lebanon

Peru2 sites

  • Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica

    Arequipa, 5154

  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

    Lima, 15036

Other trials in Peru

Colombia1 site

  • Organizacion Sanitas Internacional

    Bogota, D.C., 111321

Other trials in Colombia

Costa Rica1 site

  • Clinica CIMCA

    San José, 10103

Other trials in Costa Rica

Guatemala1 site

  • Oncomedica

    Guatemala City, 01010

Other trials in Guatemala

Panama1 site

  • The Panama Clinic

    Panama City, 0832

Other trials in Panama

Slovenia1 site

  • University Clinic Golnik

    Golnik, 4204

Other trials in Slovenia

United Arab Emirates1 site

  • Tawam Hospital

    Al Ain City, 15258

Other trials in United Arab Emirates

About this study

Official title: 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.

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AtezolizumabDrug

    Also called RO5541267, Tecentriq

    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).

Study groups in NCT03285763
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants 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).
Receives: Drug: Atezolizumab

What is being measured

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

  1. 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.

    Measured: Baseline up to 4 years

Secondary outcomes (16)

  1. 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.

    Measured: Baseline up to Year 2

  2. Overall Survival (OS)

    OS was defined as the time (in months) from initiation of study treatment to death from any cause.

    Measured: Baseline up to death (up to 4 years)

  3. 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.

    Measured: Baseline up to disease progression or death whichever occurs first (up to 4 years)

  4. 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'.

    Measured: 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)

  5. 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'.

    Measured: 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)

  6. 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'.

    Measured: 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)

  7. 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'.

    Measured: 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)

  8. 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'.

    Measured: 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)

  9. 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.

    Measured: 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)

  10. 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.

    Measured: 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)

  11. 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.

    Measured: Baseline up to disease progression or death whichever occurs first (up to 4 years)

  12. 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.

    Measured: Baseline up to Year 3

  13. 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.

    Measured: Baseline up to disease progression or death whichever occurs first (up to 4 years)

  14. 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.

    Measured: Baseline up to disease progression or death whichever occurs first (up to 4 years)

  15. 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.

    Measured: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)

  16. 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.

    Measured: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)

Timeline

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

  1. First posted18 Sep 2017
  2. Study start25 Oct 2017
  3. Primary completion7 Apr 2022
  4. Study completion7 Apr 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
619 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03285763
Sponsor's protocol ID
MO39171
Other IDs
2017-001409-34, 2017
Acronym
TAIL
Status last verified
Dec 2024
First submitted
14 Sep 2017
Last updated
23 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ardizzoni A, Azevedo S, Rubio-Viqueira B, Rodriguez-Abreu D, Alatorre-Alexander J, Smit HJM, Yu J, Syrigos K, Hoglander E, Kaul M, Tolson J, Hu Y, Vollan HK, Newsom-Davis T. Final results from TAIL: updated long-term efficacy of atezolizumab in a diverse population of patients with previously treated advanced non-small cell lung cancer. J Immunother Cancer. 2022 Nov;10(11):e005581. doi: 10.1136/jitc-2022-005581.

    PubMed 36450379

  • 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.

    PubMed 33737339

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atezolizumab in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 111 sites in 24 countries.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in Spain, Italy, United Kingdom, Greece, Netherlands and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Percentage of Participants With Adverse Events (time frame: Baseline up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285763, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in