A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Trial Title: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT03735121

Condition: Non-Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Atezolizumab

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Intervention model description: Intervention study model can be sequential or in parallel.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Atezolizumab
Description: Atezolizumab will be administered as per the schedule specified in arm or cohort.
Arm group label: Atezolizumab (Part 2)
Arm group label: Atezolizumab + rHuPH20 (Part 2)
Arm group label: Cohort 1: Atezolizumab+rHuPH20 (Part 1)
Arm group label: Cohort 2: Atezolizumab+rHuPH20 (Part 1)
Arm group label: Cohort 3: Atezolizumab+rHuPH20(Part 1)

Other name: Tecentriq

Intervention type: Drug
Intervention name: rHuPH20
Description: rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Arm group label: Atezolizumab + rHuPH20 (Part 2)
Arm group label: Cohort 1: Atezolizumab+rHuPH20 (Part 1)
Arm group label: Cohort 2: Atezolizumab+rHuPH20 (Part 1)
Arm group label: Cohort 3: Atezolizumab+rHuPH20(Part 1)

Other name: ENHANZE

Summary: This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically or cytologically documented locally advanced or metastatic NSCLC - Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen. - Measurable disease as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy ≥12 weeks - Adequate hematologic and end-organ function Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status Exclusion Criteria: - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Uncontrolled or symptomatic hypercalcemia - Pregnancy or breastfeeding - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis - Severe infection ≤ 4 weeks - Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment - Significant cardiovascular disease - Prior allogeneic stem cell or solid organ transplantation - Treatment with a live, attenuated vaccine ≤ 4 weeks - Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug - Treatment with systemic immunosuppressive medication ≤ 2 weeks Additional Exclusion Criteria (Part 2 Only) • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fundación CENIT para la Investigación en Neurociencias

Address:
City: Buenos Aires
Zip: C1125ABD
Country: Argentina

Facility:
Name: Centro Oncologico Riojano Integral (CORI)

Address:
City: La Rioja
Zip: F5300COE
Country: Argentina

Facility:
Name: Consultorio Dr. Miguel Angel Escudero

Address:
City: Salta
Zip: 4400
Country: Argentina

Facility:
Name: INCA 1- Instituto Nacional de Câncer X

Address:
City: Rio de Janeiro
Zip: 20231-050
Country: Brazil

Facility:
Name: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Hospital das Clinicas - UFRGS

Address:
City: Porto Alegre
Zip: 90035-903
Country: Brazil

Facility:
Name: Hospital Nossa Senhora da Conceicao

Address:
City: Porto Alegre
Zip: 90040-373
Country: Brazil

Facility:
Name: Instituto do Cancer do Estado de Sao Paulo - ICESP

Address:
City: Sao Paulo
Zip: 01246-000
Country: Brazil

Facility:
Name: Bradford Hill Centro de Investigaciones Clinicas

Address:
City: Recoleta
Zip: 8420383
Country: Chile

Facility:
Name: James Lind Centro de Investigación Del Cáncer

Address:
City: Temuco
Zip: 4800827
Country: Chile

Facility:
Name: ONCOCENTRO APYS; Oncología

Address:
City: Vina Del Mar
Zip: 2520598
Country: Chile

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Jilin Cancer Hospital

Address:
City: Changchun
Zip: 132013
Country: China

Facility:
Name: West China Hospital - Sichuan University

Address:
City: Chengdu City
Zip: 610047
Country: China

Facility:
Name: Cancer Center of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510000
Country: China

Facility:
Name: Sir Run Run Shaw Hospital Zhejiang University

Address:
City: Hangzhou City
Zip: 310016
Country: China

Facility:
Name: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

Address:
City: Hangzhou City
Zip: 310022
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Jinan Central Hospital

Address:
City: Jinan City
Zip: 250013
Country: China

Facility:
Name: Tianjin Cancer Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

Address:
City: Wuhan
Zip: 430023
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Clinica CIMCA

Address:
City: San José
Zip: 10103
Country: Costa Rica

Facility:
Name: ICIMED Instituto de Investigación en Ciencias Médicas

Address:
City: San José
Zip: 10108
Country: Costa Rica

Facility:
Name: Aphm; Cpcet

Address:
City: Marseille
Zip: 13385
Country: France

Facility:
Name: Ico Rene Gauducheau; Oncologie

Address:
City: Saint Herblain
Zip: 44805
Country: France

Facility:
Name: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

Address:
City: Asvestochori
Zip: 570 10
Country: Greece

Facility:
Name: Sotiria Hospital

Address:
City: Athens
Zip: 104 31
Country: Greece

Facility:
Name: INTEGRA Cancer Institute

Address:
City: Ciudad de Guatemala
Zip: 01010
Country: Guatemala

Facility:
Name: Hospital El Pilar

Address:
City: Ciudad de Guatemala
Zip: 01015
Country: Guatemala

Facility:
Name: Grupo Angeles

Address:
City: Guatemala City
Zip: 01015
Country: Guatemala

Facility:
Name: Oncomedica

Address:
City: Guatemala
Zip: 01010
Country: Guatemala

Facility:
Name: Matrai Gyogyintezet

Address:
City: Matrahaza
Zip: 3233
Country: Hungary

Facility:
Name: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Address:
City: Székesfehérvár
Zip: 8000
Country: Hungary

Facility:
Name: Református Pulmonológiai Centrum; Oncology Department

Address:
City: Törökbálint
Zip: 2045
Country: Hungary

Facility:
Name: Asst Papa Giovanni XXIII; Oncologia Medica

Address:
City: Bergamo
Zip: 24127
Country: Italy

Facility:
Name: IRCCS Istituto Clinico Humanitas; Oncologia

Address:
City: Rozzano (MI)
Zip: 20089
Country: Italy

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Centre; Medical Oncology

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Riga East Clinical University Hospital Latvian Oncology Centre

Address:
City: Riga
Zip: LV-1079
Country: Latvia

Facility:
Name: Health Pharma Professional Research

Address:
City: Cdmx
Zip: 03100
Country: Mexico

Facility:
Name: Cuidados oncologicos

Address:
City: Querétaro
Zip: 76000
Country: Mexico

Facility:
Name: Auckland City Hospital, Cancer and Blood Research

Address:
City: Auckland
Zip: 1023
Country: New Zealand

Facility:
Name: Christchurch Clinical Studies Trust Ltd

Address:
City: Christchurch
Zip: 8011
Country: New Zealand

Facility:
Name: Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre

Address:
City: Hamilton
Zip: 3204
Country: New Zealand

Facility:
Name: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

Address:
City: Tauranga
Zip: 3112
Country: New Zealand

Facility:
Name: Centro Medico Monte Carmelo

Address:
City: Arequipa
Zip: 04001
Country: Peru

Facility:
Name: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Address:
City: Lima
Zip: 15036
Country: Peru

Facility:
Name: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

Address:
City: Lima
Zip: 15088
Country: Peru

Facility:
Name: Oncosalud Sac; Oncología

Address:
City: Lima
Zip: 41
Country: Peru

Facility:
Name: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej

Address:
City: Grudzi?dz
Zip: 86-300
Country: Poland

Facility:
Name: Centrum Terapii Wspolczesnej

Address:
City: Lodz
Zip: 90-338
Country: Poland

Facility:
Name: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology

Address:
City: Otwock
Zip: 05-400
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Mordovia State University

Address:
City: Saransk
Zip: 430032
Country: Russian Federation

Facility:
Name: Chelyabinsk Regional Clinical Oncology Dispensary

Address:
City: Chelyabinsk
Zip: 454087
Country: Russian Federation

Facility:
Name: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

Address:
City: Moscow
Zip: 143422
Country: Russian Federation

Facility:
Name: Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

Address:
City: Nizhny Novgorod
Zip: 603081
Country: Russian Federation

Facility:
Name: SBIH Kaluga Region Clinical Oncology Dispensary

Address:
City: Kaluga
Zip: 248007
Country: Russian Federation

Facility:
Name: Murmansk Regional Clinical Hospital named after P.A. Bayandin

Address:
City: Murmansk
Zip: 183047
Country: Russian Federation

Facility:
Name: Multidisciplinary clinic Reaviz

Address:
City: Samara
Zip: 443011
Country: Russian Federation

Facility:
Name: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

Address:
City: Cape Town
Zip: 7506
Country: South Africa

Facility:
Name: Wilgers Oncology Centre

Address:
City: Pretoria
Zip: 0001
Country: South Africa

Facility:
Name: Sandton Oncology Medical Group

Address:
City: Sandton
Zip: 2196
Country: South Africa

Facility:
Name: Hospital Universitari Vall d'Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Universitario La Paz; Servicio de Oncologia

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Vajira Hospital

Address:
City: Bangkok
Zip: 10300
Country: Thailand

Facility:
Name: Chulalongkorn Hospital; Medical Oncology

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Facility:
Name: Rajavithi Hospital; Division of Medical Oncology

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Facility:
Name: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

Address:
City: Bangkok
Zip: 10700
Country: Thailand

Facility:
Name: Prapokklao Hospital

Address:
City: Chanthaburi
Zip: 22000
Country: Thailand

Facility:
Name: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

Address:
City: ChiangMai
Zip: 50200
Country: Thailand

Facility:
Name: Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

Address:
City: Hat Yai
Zip: 90110
Country: Thailand

Facility:
Name: Khonkaen Hospital

Address:
City: Khonkaen
Zip: 40000
Country: Thailand

Facility:
Name: Udonthani Cancer Hospital, Udonthani

Address:
City: Muang,Udonthani
Zip: 41330
Country: Thailand

Facility:
Name: Ankara Bilkent City Hospital

Address:
City: Ankara
Zip: 06490
Country: Turkey

Facility:
Name: Medipol University Medical Faculty; Oncology Department

Address:
City: Istanbul
Zip: 34214
Country: Turkey

Facility:
Name: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

Address:
City: Istanbul
Zip: 34865
Country: Turkey

Facility:
Name: Ege Uni Medical Faculty Hospital; Oncology Dept

Address:
City: Izmir
Zip: 35100
Country: Turkey

Facility:
Name: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Address:
City: Sihhiye/Ankara
Zip: 06230
Country: Turkey

Facility:
Name: Municipal Institution City Clinical Hospital #4 of Dnipro City Council

Address:
City: Dnipropetrovsk
Zip: 49102
Country: Ukraine

Facility:
Name: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

Address:
City: Kharkiv
Zip: 61070
Country: Ukraine

Facility:
Name: Ivano-Frankivsk Regional Oncology Center

Address:
City: Ivano-Frankivsk
Zip: 76018
Country: Ukraine

Facility:
Name: RCI Sumy Regional Clinical Oncological Dispensary

Address:
City: Sumy
Zip: 40005
Country: Ukraine

Facility:
Name: Birmingham Heartlands Hospital

Address:
City: Birmingham
Zip: B9 5SS
Country: United Kingdom

Facility:
Name: St James Hospital; Dept of Oncology/Hematology

Address:
City: Leeds
Zip: LS9 7TF
Country: United Kingdom

Start date: December 14, 2018

Completion date: December 31, 2024

Lead sponsor:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: Hoffmann-La Roche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03735121