Clinical trial NCT05171777: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)
timeFrame: Cycle 6 Day 1 (cycle length=21 days)
Secondary outcomes:
measure: 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)
timeFrame: Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days)
measure: Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period
timeFrame: Cycle 6 Day 1 (Cycle length=21 days)
measure: 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
timeFrame: Day 1 of Cycles 1 to 6 (cycle length= 21 days)
measure: 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
timeFrame: Cycle 6 Day 1 (cycle length=21 days)
measure: 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
timeFrame: Cycle 6 Day 1 (cycle length= 21 days)
measure: Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
timeFrame: Day 1 of Cycles 1 to 6 (cycle length=21 days)
measure: 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 - Treatment Room
timeFrame: Cycle 6 Day 1 (cycle length=21 days)
measure: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
timeFrame: Cycle 6 Day 1 (cycle length=21 days)
measure: Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room
timeFrame: Cycle 6 Day 1 (cycle length= 21 days)
measure: Change From Baseline Over Time in Participant Functioning as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
timeFrame: From Day 1 up to 30 days after last study dose (up to approximately 2 years)
measure: Change From Baseline Over Time in Symptoms as Assessed by EORTC-QLQ-C30
timeFrame: From Day 1 up to 30 days after last study dose (up to approximately 2 years)
measure: Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
timeFrame: From Day 1 up to 30 days after last study dose (up to approximately 2 years)
measure: Number of Participants With Ongoing Clinical Benefit
timeFrame: After Cycle 16 (cycle length= 21 days)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: Number of Participants With AEs During Treatment Cross-over Period
timeFrame: From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days)
Other outcomes:
Locations:
city: Brick
country: United States
facility: New Jersey Hematology Oncology Associates LLC
state: New Jersey
city: Canton
country: United States
facility: Tri County Hematologyoncology
state: Ohio
city: Medford
country: United States
facility: Asante Rogue Regional Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC - Hillman Cancer Center
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Buenos Aires
country: Argentina
facility: Cemic; Oncologia Clinica
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Oncologico Korben; Oncology
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Sault Area Hospital
state: Ontario
city: Providencia
country: Chile
facility: Fundacion Arturo Lopez Perez; Quimioterapia
city: Santiago
country: Chile
facility: OrlandiOncología
city: Temuco
country: Chile
facility: James Lind Centro de Investigación Del Cáncer
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala (OYS); Syöpätautien poliklinikka B
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala (TAYS); Syöpätautien poliklinikka
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala (TYKS); Syöpäklinikka
city: Vaasa
country: Finland
facility: VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
state: Abruzzo
city: Roma
country: Italy
facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
state: Lazio
city: Milano
country: Italy
facility: Instituto Europeo di Oncologia
state: Lombardia
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: R?ga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital Latvian Oncology Centre
city: Olsztyn
country: Poland
facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
state: LA Coruña
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Oncology
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: