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NCT05171777CompletedPhase 2

A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 11 Dec 2025

Brief summary (registry, in English)

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
179 (actual)
First submitted
29 Nov 2021
Start date
4 Apr 2022
Primary completion date
9 Nov 2023
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT05171777

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 179
  • From 4 Apr 2022 to the primary completion date, 9 Nov 2023
  • 36 sites in 12 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

  • Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

Other illness

  • History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
  • History of leptomeningeal disease
  • 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 on screening chest computed tomography (CT) scan

Lab values

  • Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene

Other

  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

Who the study is looking for

  • ECOG performance status of 0 or 1
  • Participants must have a complete resection of a histologically or cytologically confirmed Stage II, IIIA, and selected IIIB (T3-N2) NSCLC
  • PD-L1 expression TC ≥ 1% or TPS ≥ 1%
  • Participants must have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy. For participants in the adjuvant setting, neoadjuvant chemotherapy or chemoradiotherapy is acceptable provided that participants also received adjuvant chemotherapy as per protocol's requirement.
  • Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
  • Life expectancy ≥ 18 weeks in the opinion of the investigator
  • PD-L1 expression TC ≥ 50% or TPS ≥ 50% or TC3 or IC3
  • No prior systemic treatment for Stage IV non-squamous or squamous NSCLC
  • Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle.

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

Full criteria on ClinicalTrials.gov

Sites (36)

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
CEMIC
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Buenos AiresArgentinaUnknown status
Centro Oncologico Korben
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Ciudad Autonoma Buenos AiresArgentinaUnknown 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
Hospital das Clinicas - UFRGS
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Porto AlegreBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
Royal Victoria Regional Health Centre
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BarrieCanadaUnknown status
Sault Area Hospital
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Sault Ste. MarieCanadaUnknown status
OrlandiOncología
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SantiagoChileUnknown status
ICIMED Instituto de Investigación en Ciencias Médicas
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San JoséCosta RicaUnknown status
Clinica CIMCA
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San JoséCosta RicaUnknown status
Complejo Hospitalario Universitario A Coruña (CHUAC)
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A CoruñaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status
Oulun yliopistollinen sairaala (OYS)
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OuluFinlandUnknown status
Tampereen Yliopistollinen Sairaala (TAYS)
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TampereFinlandUnknown status
Turun yliopistollinen keskussairaala (TYKS)
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TurkuFinlandUnknown status
Vaasan Keskussairaala
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VaasaFinlandUnknown status
Instituto Europeo di Oncologia
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MilanItalyUnknown status
A.O.U. Maggiore della Carità
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NovaraItalyUnknown status
IRCCS Istituto Regina Elena (IFO)
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RomeItalyUnknown status
Azienda Ospedaliera Universitaria Senese
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SienaItalyUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Pauls Stradins Clinical University Hospital
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R?gaLatviaUnknown status
Riga East Clinical University Hospital Latvian Oncology Centre
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RigaLatviaUnknown status
Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie
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OlsztynPolandUnknown status
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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OtwockPolandUnknown status
New Jersey Hematology Oncology Associates LLC
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BrickUnited StatesUnknown status
Tri County Hematologyoncology
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MassillonUnited StatesUnknown status
Asante Rogue Regional Medical Center
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MedfordUnited StatesUnknown status
UPMC Hillman Cancer Center
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PittsburghUnited StatesUnknown status

Related publications

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