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

NCT ID: NCT03735121

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2024-11-11

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atezolizumab (Part 2)

Atezolizumab

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedule specified in arm or cohort.

Cohort 1: Atezolizumab+rHuPH20 (Part 1)

Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedule specified in arm or cohort.

rHuPH20

Intervention Type: DRUG

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Cohort 2: Atezolizumab+rHuPH20 (Part 1)

Atezolizumab+rHuPH20, followed by Atezolizumab

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedule specified in arm or cohort.

rHuPH20

Intervention Type: DRUG

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Cohort 3: Atezolizumab+rHuPH20(Part 1)

Atezolizumab+rHuPH20, followed by Atezolizumab

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedule specified in arm or cohort.

rHuPH20

Intervention Type: DRUG

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Atezolizumab + rHuPH20 (Part 2)

Atezolizumab + rHuPH20

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedule specified in arm or cohort.

rHuPH20

Intervention Type: DRUG

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Interventions

Atezolizumab

Atezolizumab will be administered as per the schedule specified in arm or cohort.

Intervention Type: DRUG

rHuPH20

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Intervention Type: DRUG

Other Intervention Names

Tecentriq; ENHANZE

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

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

• Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

Consultorio Dr. Miguel Angel Escudero

Salta, , Argentina

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

INCA 1- Instituto Nacional de Câncer X

Rio de Janeiro, , Brazil

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, , Chile

James Lind Centro de Investigación Del Cáncer

Temuco, , Chile

Oncocentro Apys

Viña del Mar, , Chile

Jilin Cancer Hospital

Changchun, , China

West China Hospital - Sichuan University

Chengdu, , China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, , China

Jinan Central Hospital

Jinan, , China

Henan Cancer Hospital

Zhengzhou, , China

Clinica CIMCA

San José, , Costa Rica

ICIMED Instituto de Investigación en Ciencias Médicas

San José, , Costa Rica

APHM

Marseille, , France

Ico Rene Gauducheau

Saint-Herblain, , France

General Hospital "G.Papanikolaou"

Asvestochóri, , Greece

Sotiria Hospital

Athens, , Greece

INTEGRA Cancer Institute

Guatemala City, , Guatemala

Oncomedica

Guatemala City, , Guatemala

Grupo Angeles

Guatemala City, , Guatemala

Hospital El Pilar

Guatemala City, , Guatemala

Matrai Gyogyintezet

Mátraháza, , Hungary

Református Pulmonológiai Centrum

Törökbálint, , Hungary

Asst Papa Giovanni XXIII

Bergamo, Lombardy, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, , Latvia

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

Cuidados oncologicos

Querétaro City, Querétaro, Mexico

Auckland City Hospital, Cancer and Blood Research

Auckland, , New Zealand

Christchurch Clinical Studies Trust Ltd

Christchurch, , New Zealand

Waikato Hospital - Cancer and Blood Research Trials Unit

Hamilton, , New Zealand

Tauranga Hospital, Clinical Trials Unit

Tauranga, , New Zealand

Centro Medico Monte Carmelo

Arequipa, , Peru

Clínica San Gabriel

Lima, , Peru

Oncosalud Sac

Lima, , Peru

Clinica Internacional, Sede San Borja

Lima, , Peru

Regionalny Szpital Specjalistyczny im. W. Bieganskiego

Grudzi?dz, , Poland

Centrum Terapii Wspolczesnej

Lodz, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

Warsaw, , Poland

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, Moscow Oblast, Russia

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

Moscow, Moscow Oblast, Russia

MEDSI Clinical Hospital on Pyatnitsky Highway

Moscow, Moscow Oblast, Russia

Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

Nizhny Novgorod, Niznij Novgorod, Russia

Mordovia State University

Saransk, Respublika Mordoviya, Russia

SBIH Kaluga Region Clinical Oncology Dispensary

Kaluga, , Russia

Murmansk Regional Clinical Hospital named after P.A. Bayandin

Murmansk, , Russia

Multidisciplinary clinic Reaviz

Samara, , Russia

Groote Schuur Hospital ( Uni of Capetown )

Cape Town, , South Africa

Wilgers Oncology Centre

Pretoria, , South Africa

Sandton Oncology Medical Group

Sandton, , South Africa

Asan Medical Center

Seoul, , South Korea

Samsung Medical Centre

Seoul, , South Korea

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Vajira Hospital

Bangkok, , Thailand

Chulalongkorn Hospital

Bangkok, , Thailand

Rajavithi Hospital

Bangkok, , Thailand

Faculty of Med. Siriraj Hosp.

Bangkok, , Thailand

Prapokklao Hospital

Chanthaburi, , Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Prince of Songkla University

Hat Yai, , Thailand

Udonthani Cancer Hospital, Udonthani

Muang,Udonthani, , Thailand

Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Ege Uni Medical Faculty Hospital

Izmir, , Turkey (Türkiye)

Municipal Institution City Clinical Hospital #4 of Dnipro City Council

Dnipropetrovsk, Katerynoslav Governorate, Ukraine

Communal Non profit Enterprise Regional Center of Oncology

Kharkiv, Kharkiv Governorate, Ukraine

Ivano-Frankivsk Regional Oncology Center

Ivano-Frankivsk, , Ukraine

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, , Ukraine

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Countries

Argentina; Brazil; Chile; China; Costa Rica; France; Greece; Guatemala; Hungary; Italy; Latvia; Mexico; New Zealand; Peru; Poland; Russia; South Africa; South Korea; Spain; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

References

Burotto M, Zvirbule Z, Mochalova A, Runglodvatana Y, Herraez-Baranda L, Liu SN, Chan P, Shearer-Kang E, Liu X, Tosti N, Zanghi JA, Leutgeb B, Felip E. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023 Aug;34(8):693-702. doi: 10.1016/j.annonc.2023.05.009. Epub 2023 Jun 1.

Reference Type: DERIVED

PMID: 37268157 (View on PubMed)

Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, Maiya V, Chan P, Pozzi E, Marchand M, Monchalin M, Tanaka K, Tosti N, Wang B, Restuccia E. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155. doi: 10.1002/cpdd.936. Epub 2021 Mar 31.

Reference Type: DERIVED

PMID: 33788415 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-002328-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP40657

Identifier Type: -

Identifier Source: org_study_id