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

NCT03735121 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: BP406572018-002328-18
• Study Type: interventional
• Target: 438
• Locations: 23 countries
• Sites: 74

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

Outcome Measures

Primary Outcomes (3)

• Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1

  Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2)

• Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1

  Predose on Day 1 of Cycle 2 (Cycle length =21 days)

• Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1

  From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days)

Secondary Outcomes (26)

• Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab

  Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)

• Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab

  Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)

• Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab

  Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2)

• Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration

  Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3

• Part 1: Percentage of Participants With Adverse Events (AEs)

  From initiation of study treatment up to approximately 69 months

Study Arms (5)

Atezolizumab (Part 2)

EXPERIMENTAL

Atezolizumab

Drug: Atezolizumab

Cohort 1: Atezolizumab+rHuPH20 (Part 1)

EXPERIMENTAL

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

Drug: Atezolizumab; Drug: rHuPH20

Cohort 2: Atezolizumab+rHuPH20 (Part 1)

EXPERIMENTAL

Atezolizumab+rHuPH20, followed by Atezolizumab

Drug: Atezolizumab; Drug: rHuPH20

Cohort 3: Atezolizumab+rHuPH20(Part 1)

EXPERIMENTAL

Atezolizumab+rHuPH20, followed by Atezolizumab

Drug: Atezolizumab; Drug: rHuPH20

Atezolizumab + rHuPH20 (Part 2)

EXPERIMENTAL

Atezolizumab + rHuPH20

Drug: Atezolizumab; Drug: rHuPH20

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq

Atezolizumab (Part 2); Atezolizumab + rHuPH20 (Part 2); Cohort 1: Atezolizumab+rHuPH20 (Part 1); Cohort 2: Atezolizumab+rHuPH20 (Part 1); Cohort 3: Atezolizumab+rHuPH20(Part 1)

rHuPH20 DRUG

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

Also known as: ENHANZE

Atezolizumab + rHuPH20 (Part 2); Cohort 1: Atezolizumab+rHuPH20 (Part 1); Cohort 2: Atezolizumab+rHuPH20 (Part 1); Cohort 3: Atezolizumab+rHuPH20(Part 1)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (74)

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, C1125ABD, Argentina

Location

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Location

Consultorio Dr. Miguel Angel Escudero

Salta, 4400, Argentina

Location

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

INCA 1- Instituto Nacional de Câncer X

Rio de Janeiro, 20231-050, Brazil

Location

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, 8420383, Chile

Location

James Lind Centro de Investigación Del Cáncer

Temuco, 4800827, Chile

Location

Oncocentro Apys

Viña del Mar, 2520598, Chile

Location

Jilin Cancer Hospital

Changchun, 132013, China

Location

West China Hospital - Sichuan University

Chengdu, 610047, China

Location

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

Location

Jinan Central Hospital

Jinan, 250013, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Clinica CIMCA

San José, 10103, Costa Rica

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

APHM

Marseille, 13385, France

Location

Ico Rene Gauducheau

Saint-Herblain, 44805, France

Location

General Hospital "G.Papanikolaou"

Asvestochóri, 570 10, Greece

Location

Sotiria Hospital

Athens, 104 31, Greece

Location

INTEGRA Cancer Institute

Guatemala City, 01010, Guatemala

Location

Oncomedica

Guatemala City, 01010, Guatemala

Location

Grupo Angeles

Guatemala City, 01015, Guatemala

Location

Hospital El Pilar

Guatemala City, 01015, Guatemala

Location

Matrai Gyogyintezet

Mátraháza, 3233, Hungary

Location

Református Pulmonológiai Centrum

Törökbálint, 2045, Hungary

Location

Asst Papa Giovanni XXIII

Bergamo, Lombardy, 24128, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, LV-1079, Latvia

Location

Health Pharma Professional Research

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

Location

Cuidados oncologicos

Querétaro City, Querétaro, 76000, Mexico

Location

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

Location

Christchurch Clinical Studies Trust Ltd

Christchurch, New Zealand

Location

Waikato Hospital - Cancer and Blood Research Trials Unit

Hamilton, 3204, New Zealand

Location

Tauranga Hospital, Clinical Trials Unit

Tauranga, 3112, New Zealand

Location

Centro Medico Monte Carmelo

Arequipa, 04001, Peru

Location

Clínica San Gabriel

Lima, 15088, Peru

Location

Oncosalud Sac

Lima, 41, Peru

Location

Clinica Internacional, Sede San Borja

Lima, Lima 41, Peru

Location

Regionalny Szpital Specjalistyczny im. W. Bieganskiego

Grudzi?dz, 86-300, Poland

Location

Centrum Terapii Wspolczesnej

Lodz, 93-319, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, 05-400, Poland

Location

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, Moscow Oblast, 454087, Russia

Location

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

Moscow, Moscow Oblast, 115478, Russia

Location

MEDSI Clinical Hospital on Pyatnitsky Highway

Moscow, Moscow Oblast, 143422, Russia

Location

Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

Nizhny Novgorod, Niznij Novgorod, 603081, Russia

Location

Mordovia State University

Saransk, Respublika Mordoviya, 430032, Russia

Location

SBIH Kaluga Region Clinical Oncology Dispensary

Kaluga, 248007, Russia

Location

Murmansk Regional Clinical Hospital named after P.A. Bayandin

Murmansk, 183047, Russia

Location

Multidisciplinary clinic Reaviz

Samara, 443011, Russia

Location

Groote Schuur Hospital ( Uni of Capetown )

Cape Town, 7506, South Africa

Location

Wilgers Oncology Centre

Pretoria, 0001, South Africa

Location

Sandton Oncology Medical Group

Sandton, 2196, South Africa

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Centre

Seoul, 135-170, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Vajira Hospital

Bangkok, 10300, Thailand

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Faculty of Med. Siriraj Hosp.

Bangkok, 10700, Thailand

Location

Prapokklao Hospital

Chanthaburi, 22000, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Prince of Songkla University

Hat Yai, 90110, Thailand

Location

Udonthani Cancer Hospital, Udonthani

Muang,Udonthani, 41330, Thailand

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Ege Uni Medical Faculty Hospital

Izmir, 35100, Turkey (Türkiye)

Location

Municipal Institution City Clinical Hospital #4 of Dnipro City Council

Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine

Location

Communal Non profit Enterprise Regional Center of Oncology

Kharkiv, Kharkiv Governorate, 61070, Ukraine

Location

Ivano-Frankivsk Regional Oncology Center

Ivano-Frankivsk, 76018, Ukraine

Location

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, 40005, Ukraine

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37268157 DERIVED

• 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.

  PMID: 33788415 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: Hoffman-La-Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention study model can be sequential or in parallel.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: December 27, 2018
• Primary Completion: April 26, 2022
• Study Completion: November 11, 2024
• Last Updated: December 5, 2025
• Results First Posted: June 13, 2023

Record last verified: 2025-11

Locations

BR (4); LA (1); ZA (3); RU (8); ME (2); ES (2); CL (3); CN (5); GB (1); PE (4); AR (3); KR (2); UA (4); PL (4); IT (2); GU (4); TH (8); CO (2); GR (2); NZ (4); FR (2); TU (2); HU (2)