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

NCT05171777 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MO43576
• Study Type: interventional
• Target: 179
• Locations: 12 countries
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)

  Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS.

  Cycle 6 Day 1 (cycle length=21 days)

Secondary Outcomes (27)

• Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)

  Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days)

• Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period

  Cycle 6 Day 1 (Cycle length=21 days)

• Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area

  Day 1 of Cycles 1 to 6 (cycle length= 21 days)

• Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area

  Cycle 6 Day 1 (cycle length=21 days)

• Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area

  Cycle 6 Day 1 (cycle length= 21 days)

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will receive atezolizumab SC followed by atezolizumab IV.

Drug: Atezolizumab

Treatment B

EXPERIMENTAL

Participants will receive atezolizumab IV followed by atezolizumab SC.

Drug: Atezolizumab

Interventions

Atezolizumab 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.

Also known as: Tecentriq

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (36)

New Jersey Hematology Oncology Associates LLC

Brick, New Jersey, 08724-3009, United States

Location

Tri County Hematologyoncology

Massillon, Ohio, 44646-9128, United States

Location

Asante Rogue Regional Medical Center

Medford, Oregon, 97504-8332, United States

Location

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, C1125ABD, Argentina

Location

CEMIC

Buenos Aires, C1431FWN, Argentina

Location

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

Location

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Sault Area Hospital

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

OrlandiOncología

Santiago, 7500713, Chile

Location

Clinica CIMCA

San José, 10103, Costa Rica

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

Oulun yliopistollinen sairaala (OYS)

Oulu, 90220, Finland

Location

Tampereen yliopistollinen sairaala (TAYS)

Tampere, 33521, Finland

Location

Turun yliopistollinen keskussairaala (TYKS)

Turku, 20521, Finland

Location

Vaasan Keskussairaala

Vaasa, 65130, Finland

Location

Azienda Ospedaliera Universitaria Senese

Siena, Abruzzo, 53100, Italy

Location

IRCCS Istituto Regina Elena (IFO)

Rome, Lazio, 00144, Italy

Location

Instituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

Location

A.O.U. Maggiore della Carità

Novara, Piedmont, 28100, Italy

Location

Pauls Stradins Clinical University Hospital

R?ga, LV-1002, Latvia

Location

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, LV-1079, Latvia

Location

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, 10-357, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, 05-400, Poland

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, 15006, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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. 2026 Mar;14(1):313-326. doi: 10.1007/s40487-025-00402-x. Epub 2025 Nov 26.

  PMID: 41296193 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 29, 2021
• Study Start: April 4, 2022
• Primary Completion: November 9, 2023
• Study Completion: October 25, 2024
• Last Updated: December 11, 2025
• Results First Posted: November 21, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); CL (1); BR (4); US (4); AR (3); PL (2); ES (6); FI (4); LA (2); CA (2); IT (4); CO (2)