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
Sites (74)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación CENIT para la Investigación en Neurociencias Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Oncologico Riojano Integral (Cori) Coordinator of this site? Confirm its status | La Rioja | Argentina | Unknown status |
| Consultorio Dr. Miguel Angel Escudero Coordinator of this site? Confirm its status | Salta | Argentina | Unknown status |
| Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceição Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| INCA 1- Instituto Nacional de Câncer X Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Bradford Hill Centro de Investigaciones Clinicas Coordinator of this site? Confirm its status | Recoleta | Chile | Unknown status |
| James Lind Centro De Investigacion Del Cancer Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Oncocentro Apys Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Clinica CIMCA Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| ICIMED Instituto de Investigación en Ciencias Médicas Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| APHM Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Ico Rene Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| General Hospital "G.Papanikolaou" Coordinator of this site? Confirm its status | Asvestochóri | Greece | Unknown status |
| Sotiria Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Grupo Angeles Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Oncomedica Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Hospital El Pilar Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| INTEGRA Cancer Institute Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Mátrai Gyógyintézet Coordinator of this site? Confirm its status | Mátraháza | Hungary | Unknown status |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Unknown status |
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| IRCCS Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Samsung Medical Centre Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Riga East Clinical University Hospital Latvian Oncology Centre Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Health Pharma Professional Research Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Cuidados oncologicos Coordinator of this site? Confirm its status | Querétaro City | Mexico | Unknown status |
| Auckland City Hospital, Cancer and Blood Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Clinical Studies Trust Ltd Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Waikato Hospital - Cancer and Blood Research Trials Unit Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| Tauranga Hospital, Clinical Trials Unit Coordinator of this site? Confirm its status | Tauranga | New Zealand | Unknown status |
| Centro Medico Monte Carmelo Coordinator of this site? Confirm its status | Arequipa | Peru | Unknown status |
| Clinica Internacional, Sede San Borja Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Clínica San Gabriel Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Oncosalud Sac Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Regionalny Szpital Specjalistyczny im. W. Bieganskiego Coordinator of this site? Confirm its status | Grudzi?dz | Poland | Unknown status |
| Centrum Terapii Wspolczesnej Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Coordinator of this site? Confirm its status | Otwock | Poland | Unknown status |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Chelyabinsk Regional Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| SBIH Kaluga Region Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Kaluga | Russia | Unknown status |
| MEDSI Clinical Hospital on Pyatnitsky Highway Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Murmansk Regional Clinical Hospital named after P.A. Bayandin Coordinator of this site? Confirm its status | Murmansk | Russia | Unknown status |
| Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Multidisciplinary clinic Reaviz Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| Mordovia State University Coordinator of this site? Confirm its status | Saransk | Russia | Unknown status |
| Vajira Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chulalongkorn Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Faculty of Med. Siriraj Hosp. Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Prapokklao Hospital Coordinator of this site? Confirm its status | Chanthaburi | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Prince of Songkla University Coordinator of this site? Confirm its status | Hat Yai | Thailand | Unknown status |
| Udonthani Cancer Hospital, Udonthani Coordinator of this site? Confirm its status | Muang,Udonthani | Thailand | Unknown status |
| Municipal Institution City Clinical Hospital #4 of Dnipro City Council Coordinator of this site? Confirm its status | Dnipropetrovsk | Ukraine | Unknown status |
| Ivano-Frankivsk Regional Oncology Center Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| Communal Non profit Enterprise Regional Center of Oncology Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| RCI Sumy Regional Clinical Oncological Dispensary Coordinator of this site? Confirm its status | Sumy | Ukraine | Unknown status |
| Groote Schuur Hospital ( Uni of Capetown ) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Wilgers Oncology Centre Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Sandton Oncology Medical Group Coordinator of this site? Confirm its status | Sandton | South Africa | Unknown status |
| Medipol University Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ege Uni Medical Faculty Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.