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)

NCT03285763 | Completed Phase 4 Results DMC

• 2 other identifiers: MO391712017-001409-34
• Study Type: interventional
• Target: 619
• Locations: 23 countries
• Sites: 110

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (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.

  Baseline up to 4 years

Secondary Outcomes (16)

• Percentage of Participants Alive 2 Years After Initiation of Treatment

  Baseline up to Year 2

• Overall Survival (OS)

  Baseline up to death (up to 4 years)

• Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)

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

• EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item

  Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

• EQ-5D-5L Questionnaire - Self-Care Item

  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)

Study Arms (1)

Atezolizumab

EXPERIMENTAL

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

Interventions

Atezolizumab DRUG

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).

Also known as: RO5541267, Tecentriq

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (111)

Hospital Aleman

Caba, C1118AAT, Argentina

Location

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Location

CETUS Hospital Dia Oncologia

Uberaba, Minas Gerais, 38082-049, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01327-001, Brazil

Location

Beijing Hospital

Beijing, 100006, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Organizacion Sanitas Internacional

Bogota, D.C., 111321, Colombia

Location

Clinica CIMCA

San José, 10103, Costa Rica

Location

Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

Næstved, 4700, Denmark

Location

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, 5000, Denmark

Location

Vejle Sygehus; Onkologisk Afdeling

Vejle, 7100, Denmark

Location

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, 115 22, Greece

Location

Uoa Sotiria Hospital; Oncology

Athens, 115 27, Greece

Location

Agioi Anargyroi; 3Rd Dept. of Medical Oncology

Athens, 145 64, Greece

Location

Univ General Hosp Heraklion; Medical Oncology

Heraklion, 711 10, Greece

Location

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Location

Diavalkaniko Hospital

Thessaloniki, 570 01, Greece

Location

Oncomedica

Guatemala City, 01010, Guatemala

Location

Ospedale Regionale Umberto Parini; S.C. Oncologia

Aosta, Aosta Valley, 11100, Italy

Location

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

Rionero in Vulture (PZ), Basilicate, 85028, Italy

Location

Campus Universitario S.Venuta; Centro Oncologico T.Campanella

Catanzaro, Calabria, 88100, Italy

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

Arcispedale Santa Maria Nuova; Medicina Nucleare

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

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

Rome, Lazio, 00161, Italy

Location

AZ. Ospedaliera San Giovanni - Addolorata

Rome, Lazio, 00184, Italy

Location

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

Bergamo, Lombardy, 24125, Italy

Location

ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

Brescia, Lombardy, 25123, Italy

Location

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, 20162, Italy

Location

Ospedale Oncologico A.Businco; Div. Oncologia Medica II

Cagliari, Sardinia, 09121, Italy

Location

Ospedale Cannizzaro, Oncologia

Catania, Sicily, 95126, Italy

Location

Ospedali Riuniti Di Ancona; Oncology

Ancona, The Marches, 60121, Italy

Location

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

Florence, Tuscany, 50134, Italy

Location

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

Pisa, Tuscany, 56124, Italy

Location

ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso

Treviso, Veneto, 31100, Italy

Location

Pauls Stradins Clinical University Hospital

R?ga, LV-1002, Latvia

Location

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, LV-1079, Latvia

Location

Hotel Dieu de France; Oncology

Beirut, 2063 1111, Lebanon

Location

Bellevue Medical Center

El-Metn, 2241, Lebanon

Location

University Malaya Medical Centre; Clinical Oncology Unit,

Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia

Location

Institute Kanser Negara (IKN)

Putrajaya, FED. Territory of Kuala Lumpur, 62250, Malaysia

Location

Hospital Pulau Pinang; Jabatan Respiratori

George Town, Pulau Pinang, 10450, Malaysia

Location

Mount Miriam Cancer Hospital

Pulau Pinang, Pulau Pinang, 11200, Malaysia

Location

Hospital Umum Sarawak; Oncology and Radiotherapy

Kuching, Sarawak, 93586, Malaysia

Location

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), 03100, Mexico

Location

Centro Oncologico Internacional

Mexico City, Mexico CITY (federal District), 04700, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, Oaxaca, 68000, Mexico

Location

Oncologico Potosino

San Luis Potosí City, San Luis Potosí, 78209, Mexico

Location

Investigacion Clinica Merida

Mérida, Yucatán, 97125, Mexico

Location

Clinique le Littoral

Casablanca, 20100, Morocco

Location

Centre Hospitalier Universitaire Hassan II

Fes, 30000, Morocco

Location

Institut National D'oncologie Sidi Med Benabdellah

Rabat, 6213, Morocco

Location

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Amphia Ziekenhuis; Afdeling Longziekten

Breda, 4818 CK, Netherlands

Location

Tergooiziekenhuizen, loc. Hilversum

Hilversum, 1213 HX, Netherlands

Location

UMC Radboud Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

The Panama Clinic

Panama City, 0832, Panama

Location

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

Arequipa, 5154, Peru

Location

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

Lima, 15036, Peru

Location

University of Perpetual Help System DALTA Medical Center

Las Piñas, 1740, Philippines

Location

The Medical City Hospital; Cancer Research Room

Pasig, 1605, Philippines

Location

East Avenue Medical Center

Quezon City, 1100, Philippines

Location

Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii

Gliwice, 44-101, Poland

Location

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

Olsztyn, 10-357, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

Otwock, 05-400, Poland

Location

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

Poznan, 60-569, Poland

Location

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

Warsaw, 02-781, Poland

Location

University Clinic Golnik

Golnik, 4204, Slovenia

Location

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, 39008, Spain

Location

Hospital Provincial de Castellon; Servicio de Oncologia

Castellon, Castellon, 12002, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

Hospital de Donostia; Servicio de Oncologia Medica

Donostia / San Sebastian, Guipuzcoa, 20080, Spain

Location

Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid, 28222, Spain

Location

Hospital Quiron de Madrid; Servicio de Oncologia

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Infanta Sofia; Servico de Oncologia

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Complejo Hospitalario de Navarra; Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario de Canarias;servicio de Oncologia

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital General Univ. de Alicante; Servicio de Oncologia

Alicante, 3010, Spain

Location

Hospital del Mar; Servicio de Oncologia

Barcelona, 08003, Spain

Location

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, 08036, Spain

Location

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

Barcelona, 08041, Spain

Location

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

Girona, 17007, Spain

Location

Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

Granada, 18014, Spain

Location

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

Jaén, 23007, Spain

Location

Hospital Lucus Augusti; Servicio de Oncologia

Lugo, 27003, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, 46014, Spain

Location

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, 46026, Spain

Location

Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

Zaragoza, 50009, Spain

Location

Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken

Gothenburg, 41345, Sweden

Location

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

Stockholm, 171 76, Sweden

Location

Uppsala University Hospital; Department of Oncology

Uppsala, 751 85, Sweden

Location

Tawam Hospital

Al Ain City, 15258, United Arab Emirates

Location

Royal United Hospital

Bath, BA1 3NG, United Kingdom

Location

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

Birmingham, B9 5SS, United Kingdom

Location

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

Hull, HU16 5JQ, United Kingdom

Location

Forth Valley Royal Hospital ; Oncology Department

Larbert, FK5 4QE, United Kingdom

Location

Chelsea & Westminster Hospital

London, SW10 9TH, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 36450379 DERIVED

• 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.

  PMID: 33737339 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: October 25, 2017
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Locations

LA (2); NL (6); SE (3); MO (3); CO (1); GR (6); AR (2); LE (2); ME (5); CN (5); PA (1); DK (3); ES (27); AE (1); MY (5); PE (2); GU (1); IT (16); SL (1); BR (3); PH (3); PL (5); GB (7)