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
Sites (36)
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 |
| CEMIC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Oncologico Korben Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | 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 |
| Hospital das Clinicas - UFRGS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Royal Victoria Regional Health Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| Sault Area Hospital Coordinator of this site? Confirm its status | Sault Ste. Marie | Canada | Unknown status |
| OrlandiOncología Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| ICIMED Instituto de Investigación en Ciencias Médicas Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| Clinica CIMCA Coordinator of this site? Confirm its status | San José | Costa Rica | Unknown status |
| Complejo Hospitalario Universitario A Coruña (CHUAC) Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Oulun yliopistollinen sairaala (OYS) Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Tampereen Yliopistollinen Sairaala (TAYS) Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
| Turun yliopistollinen keskussairaala (TYKS) Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Vaasan Keskussairaala Coordinator of this site? Confirm its status | Vaasa | Finland | Unknown status |
| Instituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| A.O.U. Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| IRCCS Istituto Regina Elena (IFO) Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Senese Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | R?ga | Latvia | Unknown status |
| Riga East Clinical University Hospital Latvian Oncology Centre Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Coordinator of this site? Confirm its status | Otwock | Poland | Unknown status |
| New Jersey Hematology Oncology Associates LLC Coordinator of this site? Confirm its status | Brick | United States | Unknown status |
| Tri County Hematologyoncology Coordinator of this site? Confirm its status | Massillon | United States | Unknown status |
| Asante Rogue Regional Medical Center Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
Related publications
- Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies.Lung Cancer · 2026 · PMID 42214243
- Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer.Oncol Ther · 2026 · PMID 41296193
This page is information, not medical advice. Discuss any trial with your doctor.