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

NCT ID: NCT05171777

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2024-10-25

Brief Summary

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).

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Participants will receive atezolizumab SC followed by atezolizumab IV.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4-6. This period of 3+3 cycles in both treatment arms constitutes the study Treatment Cross-over Period. After Cycle 6, participants will select how they would like atezolizumab to be administered (SC or IV) for the Treatment Continuation Period. The Treatment Continuation Period will continue until Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit, as determined by the investigator according to local standard of care, for patients with advanced NSCLC.

Treatment B

Participants will receive atezolizumab IV followed by atezolizumab SC.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4-6. This period of 3+3 cycles in both treatment arms constitutes the study Treatment Cross-over Period. After Cycle 6, participants will select how they would like atezolizumab to be administered (SC or IV) for the Treatment Continuation Period. The Treatment Continuation Period will continue until Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit, as determined by the investigator according to local standard of care, for patients with advanced NSCLC.

Interventions

Atezolizumab

Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4-6. This period of 3+3 cycles in both treatment arms constitutes the study Treatment Cross-over Period. After Cycle 6, participants will select how they would like atezolizumab to be administered (SC or IV) for the Treatment Continuation Period. The Treatment Continuation Period will continue until Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit, as determined by the investigator according to local standard of care, for patients with advanced NSCLC.

Intervention Type: DRUG

Other Intervention Names

Tecentriq

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
• History of leptomeningeal disease
• Uncontrolled or symptomatic hypercalcemia
• 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
• Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

New Jersey Hematology Oncology Associates LLC

Brick, New Jersey, United States

Tri County Hematologyoncology

Massillon, Ohio, United States

Asante Rogue Regional Medical Center

Medford, Oregon, United States

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

CEMIC

Buenos Aires, , Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, , Argentina

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

OrlandiOncología

Santiago, , Chile

Clinica CIMCA

San José, , Costa Rica

ICIMED Instituto de Investigación en Ciencias Médicas

San José, , Costa Rica

Oulun yliopistollinen sairaala (OYS)

Oulu, , Finland

Tampereen yliopistollinen sairaala (TAYS)

Tampere, , Finland

Turun yliopistollinen keskussairaala (TYKS)

Turku, , Finland

Vaasan Keskussairaala

Vaasa, , Finland

Azienda Ospedaliera Universitaria Senese

Siena, Abruzzo, Italy

IRCCS Istituto Regina Elena (IFO)

Rome, Lazio, Italy

Instituto Europeo di Oncologia

Milan, Lombardy, Italy

A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

Pauls Stradins Clinical University Hospital

R?ga, , Latvia

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, , Latvia

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Chungbuk National University Hospital

Cheongju-si, , South Korea

Asan Medical Center

Seoul, , South Korea

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Countries

United States; Argentina; Brazil; Canada; Chile; Costa Rica; Finland; Italy; Latvia; Poland; South Korea; Spain

References

Majem M, Chewaskulyong B, Zvirbule Z, Lee KH, Korbenfeld E, Kolb-Sielecki J, Castro Sanchez AY, Bustillos A, Herraez-Baranda L, Liu X, Kim SW, Cappuzzo F. Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. Oncol Ther. 2025 Nov 26. doi: 10.1007/s40487-025-00402-x. Online ahead of print.

Reference Type: DERIVED

PMID: 41296193 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MO43576

Identifier Type: -

Identifier Source: org_study_id