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NCT03735121CompletedPhase 3

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

A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 5 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
438 (actual)
First submitted
7 Nov 2018
Start date
27 Dec 2018
Primary completion date
26 Apr 2022
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT03735121
EudraCT number
2018-002328-18

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 438
  • From 27 Dec 2018 to the primary completion date, 26 Apr 2022
  • 74 sites in 23 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment
  • 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)

Other illness

  • 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
  • Significant cardiovascular disease

Other

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Uncontrolled or symptomatic hypercalcemia
  • Pregnancy or breastfeeding
  • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (74)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación CENIT para la Investigación en Neurociencias
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Buenos AiresArgentinaUnknown status
Centro Oncologico Riojano Integral (Cori)
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La RiojaArgentinaUnknown status
Consultorio Dr. Miguel Angel Escudero
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SaltaArgentinaUnknown status
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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IjuíBrazilUnknown status
Hospital Nossa Senhora da Conceição
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Porto AlegreBrazilUnknown status
INCA 1- Instituto Nacional de Câncer X
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Rio de JaneiroBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
Bradford Hill Centro de Investigaciones Clinicas
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RecoletaChileUnknown status
James Lind Centro De Investigacion Del Cancer
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TemucoChileUnknown status
Oncocentro Apys
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Viña del MarChileUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University
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HangzhouChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Clinica CIMCA
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San JoséCosta RicaUnknown status
ICIMED Instituto de Investigación en Ciencias Médicas
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San JoséCosta RicaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
APHM
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MarseilleFranceUnknown status
Ico Rene Gauducheau
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Saint-HerblainFranceUnknown status
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
General Hospital "G.Papanikolaou"
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AsvestochóriGreeceUnknown status
Sotiria Hospital
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AthensGreeceUnknown status
Grupo Angeles
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Guatemala CityGuatemalaUnknown status
Oncomedica
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Guatemala CityGuatemalaUnknown status
Hospital El Pilar
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Guatemala CityGuatemalaUnknown status
INTEGRA Cancer Institute
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Guatemala CityGuatemalaUnknown status
Mátrai Gyógyintézet
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MátraházaHungaryUnknown status
Református Pulmonológiai Centrum
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TörökbálintHungaryUnknown status
Asst Papa Giovanni XXIII
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BergamoItalyUnknown status
IRCCS Istituto Clinico Humanitas
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RozzanoItalyUnknown status
Samsung Medical Centre
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Riga East Clinical University Hospital Latvian Oncology Centre
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RigaLatviaUnknown status
Health Pharma Professional Research
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Mexico CityMexicoUnknown status
Cuidados oncologicos
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Querétaro CityMexicoUnknown status
Auckland City Hospital, Cancer and Blood Research
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AucklandNew ZealandUnknown status
Christchurch Clinical Studies Trust Ltd
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ChristchurchNew ZealandUnknown status
Waikato Hospital - Cancer and Blood Research Trials Unit
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HamiltonNew ZealandUnknown status
Tauranga Hospital, Clinical Trials Unit
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TaurangaNew ZealandUnknown status
Centro Medico Monte Carmelo
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ArequipaPeruUnknown status
Clinica Internacional, Sede San Borja
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LimaPeruUnknown status
Clínica San Gabriel
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LimaPeruUnknown status
Oncosalud Sac
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LimaPeruUnknown status
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
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Grudzi?dzPolandUnknown status
Centrum Terapii Wspolczesnej
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LodzPolandUnknown status
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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OtwockPolandUnknown status
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
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WarsawPolandUnknown status
Chelyabinsk Regional Clinical Oncology Dispensary
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ChelyabinskRussiaUnknown status
SBIH Kaluga Region Clinical Oncology Dispensary
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KalugaRussiaUnknown status
MEDSI Clinical Hospital on Pyatnitsky Highway
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MoscowRussiaUnknown status
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
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MoscowRussiaUnknown status
Murmansk Regional Clinical Hospital named after P.A. Bayandin
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MurmanskRussiaUnknown status
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
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Nizhny NovgorodRussiaUnknown status
Multidisciplinary clinic Reaviz
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SamaraRussiaUnknown status
Mordovia State University
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SaranskRussiaUnknown status
Vajira Hospital
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BangkokThailandUnknown status
Chulalongkorn Hospital
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BangkokThailandUnknown status
Rajavithi Hospital
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BangkokThailandUnknown status
Faculty of Med. Siriraj Hosp.
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BangkokThailandUnknown status
Prapokklao Hospital
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ChanthaburiThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital
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Chiang MaiThailandUnknown status
Prince of Songkla University
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Hat YaiThailandUnknown status
Udonthani Cancer Hospital, Udonthani
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Muang,UdonthaniThailandUnknown status
Municipal Institution City Clinical Hospital #4 of Dnipro City Council
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DnipropetrovskUkraineUnknown status
Ivano-Frankivsk Regional Oncology Center
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Ivano-FrankivskUkraineUnknown status
Communal Non profit Enterprise Regional Center of Oncology
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KharkivUkraineUnknown status
RCI Sumy Regional Clinical Oncological Dispensary
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SumyUkraineUnknown status
Groote Schuur Hospital ( Uni of Capetown )
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Cape TownSouth AfricaUnknown status
Wilgers Oncology Centre
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PretoriaSouth AfricaUnknown status
Sandton Oncology Medical Group
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SandtonSouth AfricaUnknown status
Medipol University Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Ege Uni Medical Faculty Hospital
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IzmirTurkey (Türkiye)Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.