Clinical trial NCT03285763: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to 4 years
Secondary outcomes:
measure: Percentage of Participants Alive 2 Years After Initiation of Treatment
timeFrame: Baseline up to Year 2
measure: Overall Survival (OS)
timeFrame: Baseline up to death (up to 4 years)
measure: 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)
timeFrame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item
timeFrame: 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)
measure: EQ-5D-5L Questionnaire - Self-Care Item
timeFrame: 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)
measure: EQ-5D-5L Questionnaire - Usual Activities Item
timeFrame: 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)
measure: EQ-5D-5L Questionnaire - Pain/Discomfort Item
timeFrame: 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)
measure: EQ-5D-5L Questionnaire - Anxiety/Depression Item
timeFrame: 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)
measure: EQ-5D-5L Questionnaire - VAS Scores
timeFrame: 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)
measure: European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)
timeFrame: 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)
measure: Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST
timeFrame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: Percentage of Participants Alive 3 Years After Initiation of Treatment
timeFrame: Baseline up to Year 3
measure: Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1
timeFrame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST
timeFrame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: Duration of Response as Assessed by the Investigator According to RECIST v.1.1
timeFrame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
measure: Duration of Response as Assessed by the Investigator According to Modified RECIST
timeFrame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital Aleman
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Uberaba
country: Brazil
facility: CETUS Hospital Dia Oncologia
state: MG
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
state: SP
city: Beijing City
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Bogota, D.C.
country: Colombia
facility: Organizacion Sanitas Internacional
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: Naestved
country: Denmark
facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Vejle
country: Denmark
facility: Vejle Sygehus; Onkologisk Afdeling
city: Athens
country: Greece
facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
city: Athens
country: Greece
facility: Uoa Sotiria Hospital; Oncology
city: Athens
country: Greece
facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Diavalkaniko Hospital
city: Guatemala
country: Guatemala
facility: Oncomedica
city: Rionero In Vulture (PZ)
country: Italy
facility: Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica
state: Basilicata
city: Catanzaro
country: Italy
facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella
state: Calabria
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Medicina Nucleare
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
state: Lazio
city: Roma
country: Italy
facility: AZ. Ospedaliera San Giovanni - Addolorata
state: Lazio
city: Bergamo
country: Italy
facility: Cliniche Gavazzeni S.p.A.; Dip. di Oncologia Pneumologica ed Urologica
state: Lombardia
city: Brescia
country: Italy
facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Ancona
country: Italy
facility: Ospedali Riuniti Di Ancona; Oncology
state: Marche
city: Cagliari
country: Italy
facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II
state: Sardegna
city: Catania
country: Italy
facility: Ospedale Cannizzaro, Oncologia
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
state: Toscana
city: Aosta
country: Italy
facility: Ospedale Regionale Umberto Parini; S.C. Oncologia
state: Valle D?Aosta
city: Treviso
country: Italy
facility: ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso
state: Veneto
city: R?ga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital Latvian Oncology Centre
city: Beirut
country: Lebanon
facility: Hotel Dieu de France; Oncology
city: El-Metn
country: Lebanon
facility: Bellevue Medical Center
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre; Clinical Oncology Unit,
state: FED. Territory OF Kuala Lumpur
city: Putrajaya
country: Malaysia
facility: Institute Kanser Negara (IKN)
state: FED. Territory OF Kuala Lumpur
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang; Jabatan Respiratori
state: Penang
city: Pulau Pinang
country: Malaysia
facility: Mount Miriam Cancer Hospital
state: Penang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak; Oncology and Radiotherapy
state: Sarawak
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Mexico D.F.
country: Mexico
facility: Centro Oncologico Internacional
state: Mexico CITY (federal District)
city: Oaxaca de Juárez
country: Mexico
facility: Oaxaca Site Management Organization
state: Oaxaca
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
state: SAN LUIS Potosi
city: Mérida
country: Mexico
facility: Investigacion Clinica Merida
state: Yucatan
city: Casablanca
country: Morocco
facility: Clinique le Littoral
city: FES
country: Morocco
facility: Centre Hospitalier Universitaire Hassan II
city: Rabat
country: Morocco
facility: Institut National D'oncologie Sidi Med Benabdellah
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis; Afdeling Longziekten
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen, loc. Hilversum
city: Nijmegen
country: Netherlands
facility: UMC Radboud Nijmegen
city: Zwolle
country: Netherlands
facility: Isala
city: Panama
country: Panama
facility: The Panama Clinic
city: Arequipa
country: Peru
facility: Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
city: Las Pinas
country: Philippines
facility: University of Perpetual Help System DALTA Medical Center
city: Pasig
country: Philippines
facility: The Medical City Hospital; Cancer Research Room
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
city: Poznan
country: Poland
facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
city: Warszawa
country: Poland
facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
city: Golnik
country: Slovenia
facility: University Clinic Golnik
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Oncologia
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Castellon de La Plana
country: Spain
facility: Hospital Provincial de Castellon; Servicio de Oncologia
state: Castellon
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: San Sebastian
country: Spain
facility: Hospital de Donostia; Servicio de Oncologia Medica
state: Guipuzcoa
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases; Servicio de Oncologia
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
state: LAS Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Oncologia
state: Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: Hospital Infanta Sofia; Servico de Oncologia
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra; Servicio de Oncologia
state: Navarra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
city: Goeteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
city: Uppsala
country: Sweden
facility: Uppsala University Hospital; Department of Oncology
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital ; Department of Respiratory Medicine (Rm 30)
city: Hull
country: United Kingdom
facility: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital ; Oncology Department
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
References:
citation: 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.