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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundación Cenit Para La Investigación En Neurociencias
  • Buenos Aires, Argentina, C1431FWN
    • Cemic; Oncologia Clinica
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben; Oncology
• Brazil
  • RS
    • Ijui, RS, Brazil, 98700-000
      • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
    • Porto Alegre, RS, Brazil, 90040-373
      • Hospital Nossa Senhora Da Conceição
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
    • Sault Ste. Marie, Ontario, Canada, P6B 0A8
      • Sault Area Hospital
• Chile
  • Providencia, Chile, 7500921
    • Fundacion Arturo Lopez Perez; Quimioterapia
  • Santiago, Chile, 7500713
    • OrlandiOncología
  • Temuco, Chile, 4800827
    • James Lind Centro de Investigación del Cáncer
• Costa Rica
  • San José, Costa Rica, 10103
    • Clinica CIMCA
  • San José, Costa Rica, 10108
    • ICIMED Instituto de Investigación en Ciencias Médicas
• Finland
  • Oulu, Finland, 90220
    • Oulun yliopistollinen sairaala (OYS); Syöpätautien poliklinikka B
  • Tampere, Finland, 33521
    • Tampereen yliopistollinen sairaala (TAYS); Syöpätautien poliklinikka
  • Turku, Finland, 20521
    • Turun yliopistollinen keskussairaala (TYKS); Syöpäklinikka
  • Vaasa, Finland, 65130
    • VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
• Italy
  • Abruzzo
    • Siena, Abruzzo, Italy, 53100
      • Azienda Ospedaliera Universitaria Senese
  • Lazio
    • Roma, Lazio, Italy, 00144
      • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
  • Lombardia
    • Milano, Lombardia, Italy, 20141
      • Instituto Europeo Di Oncologia
  • Piemonte
    • Novara, Piemonte, Italy, 28100
      • A.O.U. Maggiore della Carita
• Korea, Republic of
  • Cheongju si, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
• Latvia
  • R?ga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital Latvian Oncology Centre
• Poland
  • Olsztyn, Poland, 10-357
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron; Oncology
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Oncologia
• United States
  • New Jersey
    • Brick, New Jersey, United States, 08724-3009
      • New Jersey Hematology Oncology Associates Llc
  • Ohio
    • Canton, Ohio, United States, 44718
      • Tri County Hematologyoncology
  • Oregon
    • Medford, Oregon, United States, 97504-8332
      • Asante Rogue Regional Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC - Hillman Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for All Participants:

• ECOG performance status of 0 or 1

Inclusion Criteria for Participants with Early-stage NSCLC:

• 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.

Inclusion Criteria for Participants with Stage IV NSCLC:

• 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 for All Participants:

• 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

Exclusion Criteria for Participants with Stage IV NSCLC:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Participants will receive atezolizumab SC followed by atezolizumab IV.	Drug: 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.; Other Names: Tecentriq
Experimental: Treatment B; Participants will receive atezolizumab IV followed by atezolizumab SC.	Drug: 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.; Other Names: Tecentriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Preferred Atezolizumab SC to Atezolizumab IV	Proportion of participants who preferred atezolizumab SC to atezolizumab IV, with treatment preference assessed using Question 1 of the Patient Preference Questionnaire (PPQ).	Following treatment administration on Day 1 of Cycle 6 (cycle length is 21 days) of the Treatment Cross-over Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-Reported Satisfaction With Atezolizumab SC and Atezolizumab IV	Evaluate participant-reported satisfaction with atezolizumab SC and atezolizumab IV assessed using Question 1 of the Therapy Administration Satisfaction Questionnaire - subcutaneous (TASQ-SC) and TASQ - intravenous (TASQ-IV).	Following treatment administration on Day 1 of Cycles 3 and 6 (cycle length is 21 days) of the Treatment Cross-over Period
Proportion of Participants Who Select Atezolizumab SC	Evaluate participants' choice of atezolizumab SC for the Treatment Continuation Period based on the proportion of participants who select atezolizumab SC for this study period	After Cycle 6 (Cycle length is 21 days)
HCP Perception of Time/Resource Use With Atezolizumab SC Compared to Atezolizumab IV	Evaluate HCP perception of time/resource use with atezolizumab SC compared to IV based on HCP responses to the Healthcare Professional Questionnaires (HCPQs), by individual question.	During Treatment Cross-over Period (3+3 cycles; each cycle is 21days)
HCP Perception of Convenience for Administration With Atezolizumab SC Compared to Atezolizumab IV	Evaluate HCP perception of convenience for administration with atezolizumab SC and IV based on HCP responses to the Healthcare Professional Questionnaires (HCPQs), by individual question.	After administration of each participant's treatment Cycle 6 (cycle length is 21 days)
Change in Symptoms, as Assessed by EORTC QLQ-C30 Scores	Change in symptoms from baseline and over time as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) scores.	Baseline and over time (through approximately 2 years)
Change in Function, as Assessed by EORTC QLQ-C30 Scores	Change in function from baseline and over time as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) scores.	Baseline and over time (through approximately 2 years)
Changes in Score in HRQoL	Changes from baseline score in HRQoL by cycle as assessed by the Global Health Status/Quality of Life (GHS/QoL) scale (items 29 and 30) of the EORTC QLQ-C30.	Baseline and over time (through approximately 2 years)
Percentage of Participants With Continuing Clinical Benefit	Percentage of participants with continuing clinical benefit after 16 cycles of atezolizumab, as assessed by the investigator according to local standard of care.	After Cycle 16 (each cycle is 21 days)
Percentage of Participants With Adverse Events		Up to approximately 2 years
Percentage of Participants With Adverse Events During Treatment Cross-over Period		During the study Treatment Cross-over Period (3+3 cycles; each cycle is 21days)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): November 9, 2023
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: MO43576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No