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TAIL: 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)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03285763
Collaborator
(none)
619
Enrollment
112
Locations
1
Arm
53.4
Actual Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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] 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
619 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 25, 2017
Actual Primary Completion Date :
Apr 7, 2022
Actual Study Completion Date :
Apr 7, 2022

Arms and Interventions

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:
  • RO5541267
  • Tecentriq

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Adverse Events [Baseline up to 4 years]

    Secondary Outcome Measures

    1. Percentage of Participants Alive 2 Years After Initiation of Treatment [Baseline up to Year 2]

    2. Overall Survival (OS) [Baseline up to death (up to 4 years)]

    3. Progression-Free Survival Based on Disease Status as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1) [Baseline up to disease progression or death whichever occurs first (up to 4 years)]

    4. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire [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)]

    5. European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13) [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)]

    6. Progression-Free Survival Based on Disease Status as Evaluated By the Investigator in Accordance With Modified RECIST [Baseline up to disease progression or death whichever occurs first (up to 4 years)]

    7. Percentage of Participants Alive 3 Years After Initiation of Treatment [Baseline up to Year 3]

    8. Percentage of Participants with Objective Reponse as Assessed by the Investigator According to RECIST v1.1 [Baseline up to disease progression or death whichever occurs first (up to 4 years)]

    9. Percentage of Participants with Objective Reponse as Assessed by the Investigator According to Modified RECIST [Baseline up to disease progression or death whichever occurs first (up to 4 years)]

    10. Duration of Response as Assessed by the Investigator According to RECIST v.1.1 [From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)]

    11. Duration of Response as Assessed by the Investigator According to Modified RECIST [From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Aleman Caba Argentina C1118AAT
    2 Centro Oncologico Riojano Integral (CORI) La Rioja Argentina F5300COE
    3 CETUS Hospital Dia Oncologia Uberaba MG Brazil 38082-049
    4 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    5 Centro de Pesquisas Oncologicas - CEPON Florianopolis SC Brazil 88034-000
    6 Hospital Alemao Oswaldo Cruz Sao Paulo SP Brazil 01323-903
    7 Beijing Hospital Beijing City China 100006
    8 Chinese PLA General Hospital Beijing China 100853
    9 Shandong Cancer Hospital Jinan China 250117
    10 First Affiliated Hospital of Soochow University Suzhou China 215006
    11 Henan Cancer Hospital Zhengzhou China 450008
    12 Organizacion Sanitas Internacional Bogota, D.C. Colombia 111321
    13 Clinica CIMCA San José Costa Rica 10103
    14 Sjællands Universitetshospital, Næstved; Onkologisk Afdeling Naestved Denmark 4700
    15 Odense Universitetshospital, Onkologisk Afdeling R Odense C Denmark 5000
    16 Vejle Sygehus; Onkologisk Afdeling Vejle Denmark 7100
    17 Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine Athens Greece 115 22
    18 Uoa Sotiria Hospital; Oncology Athens Greece 115 27
    19 Agioi Anargyroi; 3Rd Dept. of Medical Oncology Athens Greece 145 64
    20 Univ General Hosp Heraklion; Medical Oncology Heraklion Greece 711 10
    21 University Hospital of Patras Medical Oncology Patras Greece 265 04
    22 Diavalkaniko Hospital Thessaloniki Greece 570 01
    23 Oncomedica Guatemala Guatemala 01010
    24 Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica Rionero In Vulture (PZ) Basilicata Italy 85028
    25 Campus Universitario S.Venuta; Centro Oncologico T.Campanella Catanzaro Calabria Italy 88100
    26 Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Bologna Emilia-Romagna Italy 40138
    27 Arcispedale Santa Maria Nuova; Medicina Nucleare Reggio Emilia Emilia-Romagna Italy 42100
    28 Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche Roma Lazio Italy 00161
    29 AZ. Ospedaliera San Giovanni - Addolorata Roma Lazio Italy 00184
    30 Cliniche Gavazzeni S.p.A.; Dip. di Oncologia Pneumologica ed Urologica Bergamo Lombardia Italy 24125
    31 ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica Brescia Lombardia Italy 25123
    32 Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia Milano Lombardia Italy 20162
    33 Ospedali Riuniti Di Ancona; Oncology Ancona Marche Italy 60121
    34 Ospedale Oncologico A.Businco; Div. Oncologia Medica II Cagliari Sardegna Italy 09121
    35 Ospedale Cannizzaro, Oncologia Catania Sicilia Italy 95126
    36 Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia Firenze Toscana Italy 50134
    37 Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare Pisa Toscana Italy 56124
    38 Ospedale Regionale Umberto Parini; S.C. Oncologia Aosta Valle D'Aosta Italy 11100
    39 ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso Treviso Veneto Italy 31100
    40 Riga East Clinical University Hospital Latvian Oncology Centre Riga Latvia LV-1079
    41 Pauls Stradins Clinical University Hospital Rīga Latvia LV-1002
    42 Hotel Dieu de France; Oncology Beirut Lebanon 2063 1111
    43 Bellevue Medical Center El-Metn Lebanon 2241
    44 Institute Kanser Negara (IKN) Putrajaya FED. Territory OF Kuala Lumpur Malaysia 62250
    45 Hospital Pulau Pinang; Jabatan Respiratori Georgetown Penang Malaysia 10450
    46 University Malaya Medical Centre; Clinical Oncology Unit, Kuala Lumpur Malaysia 59100
    47 Hospital Umum Sarawak; Oncology and Radiotherapy Kuching Malaysia 93586
    48 Mount Miriam Cancer Hospital Tanjung Bungah Malaysia 11200
    49 Health Pharma Professional Research Cdmx Mexico CITY (federal District) Mexico 03100
    50 Oncologico Potosino San Luis Potosí SAN LUIS Potosi Mexico 78209
    51 Investigacion Clinica Merida Mérida Yucatan Mexico 97125
    52 Centro Oncologico Internacional Mexico D.F. Mexico 04700
    53 Oaxaca Site Management Organization Oaxaca Mexico 68000
    54 Clinique le Littoral Casablanca Morocco 20100
    55 Centre Hospitalier Universitaire Hassan II FES Morocco 30000
    56 Institut National D'oncologie Sidi Med Benabdellah Rabat Morocco 6213
    57 Meander Medisch Centrum Amersfoort Netherlands 3813 TZ
    58 Ziekenhuis Rijnstate Arnhem Netherlands 6815 AD
    59 Amphia Ziekenhuis; Afdeling Longziekten Breda Netherlands 4818 CK
    60 Tergooiziekenhuizen, loc. Hilversum Hilversum Netherlands 1213 HX
    61 UMC Radboud Nijmegen Nijmegen Netherlands 6500 HB
    62 Isala Zwolle Netherlands 8025 AB
    63 Centro Hemato Oncologico Panama Panama Panama 0832
    64 Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica Arequipa Peru 5154
    65 Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional Lima Peru Lima 41
    66 University of Perpetual Help System DALTA Medical Center Las Pinas Philippines 1740
    67 The Medical City Hospital; Cancer Research Room Pasig Philippines 1605
    68 East Avenue Medical Center Quezon City Philippines 1100
    69 Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii Gliwice Poland 44-101
    70 Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie Olsztyn Poland 10-357
    71 Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Otwock Poland 05-400
    72 Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna Poznan Poland 60-569
    73 Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers Warszawa Poland 02-781
    74 University Clinic Golnik Golnik Slovenia 4204
    75 Hospital Univ. Central de Asturias; Servicio de Oncologia Oviedo Asturias Spain 33011
    76 Hospital Universitario Marques de Valdecilla; Servicio de Oncologia Santander Cantabria Spain 39008
    77 Hospital Provincial de Castellon; Servicio de Oncologia Castellon de La Plana Castellon Spain 12002
    78 Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba Cordoba Spain 14004
    79 Hospital de Donostia; Servicio de Oncologia Medica San Sebastian Guipuzcoa Spain 20080
    80 Hospital Universitario Son Espases; Servicio de Oncologia Palma De Mallorca Islas Baleares Spain 07014
    81 Complejo Hospitalario Universitario Insular-Materno Infantil; Servicio de Oncologia Las Palmas de Gran Canaria LAS Palmas Spain 35016
    82 Hospital Universitario Puerta de Hierro; Servicio de Oncologia Majadahonda Madrid Spain 28222
    83 Hospital Quiron de Madrid; Servicio de Oncologia Pozuelo de Alarcon Madrid Spain 28223
    84 Hospital Infanta Sofia; Servico de Oncologia San Sebastian de Los Reyes Madrid Spain 28702
    85 Complejo Hospitalario de Navarra; Servicio de Oncologia Pamplona Navarra Spain 31008
    86 Hospital Universitario de Canarias;servicio de Oncologia La Laguna Tenerife Spain 38320
    87 Hospital General Univ. de Alicante; Servicio de Oncologia Alicante Spain 3010
    88 Hospital del Mar; Servicio de Oncologia Barcelona Spain 08003
    89 Hospital Clínic i Provincial; Servicio de Hematología y Oncología Barcelona Spain 08036
    90 Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Barcelona Spain 08041
    91 Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica Girona Spain 17007
    92 Hospital Universitario Virgen de las Nieves; Servicio de Oncologia Granada Spain 18014
    93 Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen Spain 23007
    94 Hospital Lucus Augusti; Servicio de Oncologia Lugo Spain 27003
    95 Hospital Ramon y Cajal; Servicio de Oncologia Madrid Spain 28034
    96 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
    97 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    98 Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla Spain 41013
    99 Hospital General Universitario de Valencia; Servicio de oncologia Valencia Spain 46014
    100 Hospital Universitario la Fe; Servicio de Oncologia Valencia Spain 46026
    101 Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia Zaragoza Spain 50009
    102 Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken Goeteborg Sweden 41345
    103 Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01 Stockholm Sweden 171 76
    104 Uppsala University Hospital; Department of Oncology Uppsala Sweden 751 85
    105 Tawam Hospital Al Ain United Arab Emirates 15258
    106 Royal United Hospital Bath United Kingdom BA1 3NG
    107 Birmingham Heartlands Hospital ; Department of Respiratory Medicine (Rm 30) Birmingham United Kingdom B9 5SS
    108 Castle Hill Hospital; The Queen's Centre for Oncology & Haematology Hull United Kingdom HU16 5JQ
    109 Forth Valley Royal Hospital ; Oncology Department Larbert United Kingdom FK5 4QE
    110 Chelsea & Westminster Hospital London United Kingdom SW10 9NH
    111 Mount Vernon Cancer Centre Northwood United Kingdom HA6 2RN
    112 New Cross Hospital Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03285763
    Other Study ID Numbers:
    • MO39171
    • 2017-001409-34
    First Posted:
    Sep 18, 2017
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Atezolizumab

    Study Results

    No Results Posted as of May 26, 2022