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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05171777
• Other study ID #: MO43576
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 4, 2022
• Est. completion date: September 20, 2024

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: September 20, 2024
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Argentina	Cemic; Oncologia Clinica	Buenos Aires
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Argentina	Centro Oncologico Korben; Oncology	Ciudad Autonoma Buenos Aires
Brazil	Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda	Ijui	RS
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Canada	Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials	Barrie	Ontario
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Sault Area Hospital	Sault Ste. Marie	Ontario
Chile	Fundacion Arturo Lopez Perez; Quimioterapia	Providencia
Chile	OrlandiOncología	Santiago
Chile	James Lind Centro de Investigación Del Cáncer	Temuco
Costa Rica	Clinica CIMCA	San José
Costa Rica	ICIMED Instituto de Investigación en Ciencias Médicas	San José
Finland	Oulun yliopistollinen sairaala (OYS); Syöpätautien poliklinikka B	Oulu
Finland	Tampereen yliopistollinen sairaala (TAYS); Syöpätautien poliklinikka	Tampere
Finland	Turun yliopistollinen keskussairaala (TYKS); Syöpäklinikka	Turku
Finland	VAASAN KESKUSSAIRAALA; Onkologian poliklinikka	Vaasa
Italy	Instituto Europeo di Oncologia	Milano	Lombardia
Italy	A.O.U. Maggiore della Carità	Novara	Piemonte
Italy	IRCCS Istituto Regina Elena (IFO); Oncologia Medica B	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Senese	Siena	Abruzzo
Korea, Republic of	Chungbuk National University Hospital	Cheongju si
Korea, Republic of	Asan Medical Center	Seoul
Latvia	Pauls Stradins Clinical University Hospital	R?ga
Latvia	Riga East Clinical University Hospital Latvian Oncology Centre	Riga
Poland	Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc	Otwock
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia	A Coruña	LA Coruña
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Oncology	Barcelona
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia	Zaragoza
United States	New Jersey Hematology Oncology Associates LLC	Brick	New Jersey
United States	Tri County Hematologyoncology	Canton	Ohio
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	UPMC - Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  Costa Rica,  Finland,  Italy,  Korea, Republic of,  Latvia,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Percentage of Participants With Adverse Events		Up to approximately 2 years
Secondary	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)