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)

Carcinoma, Non-Small-Cell Lung Clinical Trial

— TAIL  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285763
• Other study ID #: MO39171
• Secondary ID: 2017-001409-34
• Status: Completed
• Phase: Phase 4
• Start date: October 25, 2017
• Est. completion date: April 7, 2022

Study information

• Verified date: May 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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] 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Brazil,  China,  Colombia,  Costa Rica,  Denmark,  Greece,  Guatemala,  Italy,  Latvia,  Lebanon,  Malaysia,  Mexico,  Morocco,  Netherlands,  Panama,  Peru,  Philippines,  Poland,  Slovenia,  Spain,  Sweden,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events		Baseline up to 4 years
Secondary	Percentage of Participants Alive 2 Years After Initiation of Treatment		Baseline up to Year 2
Secondary	Overall Survival (OS)		Baseline up to death (up to 4 years)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Percentage of Participants Alive 3 Years After Initiation of Treatment		Baseline up to Year 3
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)