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
- Registration Number
- NCT05171777
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A Atezolizumab Participants will receive atezolizumab SC followed by atezolizumab IV. Treatment B Atezolizumab Participants will receive atezolizumab IV followed by atezolizumab SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) Cycle 6 Day 1 (cycle length=21 days) 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.
- Secondary Outcome Measures
Name Time Method 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) TASQ is a 12-item, participant-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Crossover Period. Participants satisfaction was assessed based on the Question 1 of TASQ-IV/SC which asks participants about their satisfaction with respect to route of administration (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, participant did not answer the question). Question 1 - TASQ- IV (How satisfied or dissatisfied were you with the IV infusion?) and TASQ- SC (How satisfied or dissatisfied were you with the SC injection?)
Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period Cycle 6 Day 1 (Cycle length=21 days) At Cycle 6, Day 1, participants were expected to select the route of study treatment administration (SC or IV) they would like to receive during the Treatment Continuation Period (starting at Cycle 7). Percentage of participants who chose SC administration have been reported here. Percentages have been rounded off.
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) The HCPQ- Drug Preparation Area Question 1 was completed by the HCPs within the pharmacy/drug preparation area where atezolizumab IV reconstitution or atezolizumab SC was prepared before the actual drug administration took place. The HCPQs were completed for every participant at each treatment cycle (Cycles 1-6, i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC or vice versa) of the treatment cross-over period. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to prepare the IV infusion/SC injection of atezolizumab: "How long (in minutes) did it take to prepare the treatment for use?"
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) HCPs within pharmacy/drug preparation area responded to HCPQ-Drug Preparation Area Question 2 at Cycle 6 of Treatment Crossover Period for every participant: "If all IV infusions are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a=Staff will have increased availability for other tasks in pharmacy; b=Administrative procedures around atezolizumab SC will require less time; c=Atezolizumab SC formulations will provide more flexibility for staff in managing their workload; d=Due to ready-to-use atezolizumab SC formulations, potential dosing errors will be avoided; e=Due to ready-to-use atezolizumab SC formulations, there will be less drug wastage; f=Without having to reconstitute the drug, less storage space for atezolizumab SC related supplies will be required in pharmacy; g=Preparation procedures \& associated time staff time commitment will be reduced, h=It will ease drug administration for participants with difficult venous access."
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) HCPs who prepared study treatment within the pharmacy/drug preparation area responded at to the following HCPQ-Drug Preparation Area Questions 3 and 4, at Cycle 6 of the Treatment Crossover Period for every participant: "Looking back over the Atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Question 4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The four available response options were: Atezolizumab IV, Atezolizumab SC, No Difference, and Missing. Percentages have been rounded off.
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room Day 1 of Cycles 1 to 6 (cycle length=21 days) The HCPQ-Treatment Room Question 1 was completed for every participant at each treatment cycle of the Treatment Crossover Period (Cycles 1-6,i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC/vice versa) by HCPs who administered treatment to the study participants. HCPs responded to following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter (PICC)/peripheral vein cannulation) \& how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the participant in the treatment room for in total?" Durations with non-zero HCP responders have been reported here.
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 Cycle 6 Day 1 (cycle length=21 days) HCPs who administered treatment responded to Question 2: If all IV are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a= Participants will be moved outside of infusion unit to receive SC injections (physician consultation room); b=Atezolizumab SC route will allow more flexible treatment scheduling; c=More participants will be treated in infusion unit; d=Waiting list for any IV treatment at infusion unit will be reduced; e=Staff resources will be re distributed to other departments of the hospital (less staffing required within infusion unit); f=There will still be sufficient interaction time between HCPs \& participants (for participant education); g=Staff will spend more time for further professional education/development; h=Staff will dedicate more time to attending to administrative tasks for participants; i=Participants will spend less time in care unit; j=Administration by atezolizumab SC injection is preferred by participants.
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 Cycle 6 Day 1 (cycle length=21 days) HCPs who administered study treatment responded at Cycle 6 of the Treatment Crossover Period to the following HCPQ-treatment room Questions 3 to 7: "Looking back over the atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Which method was most convenient for the participant? Question 4. Which method was best for optimizing participant care in your center? Question 5. Which method took the least time from start to finish of administration? Question 6. Which method required the least resource use for administration? Question 7. Which method was preferred by participants?" The five available response options were: Atezolizumab SC, Atezolizumab IV, No Difference, Unsure and Missing. Percentages have been rounded off.
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 Cycle 6 Day 1 (cycle length= 21 days) HCPs who administered study treatment responded at Cycle 6 of the treatment Cross-over Period to the following HCPQ-treatment room Question 8: How frequently would you offer or recommend atezolizumab SC administration to your participants in the future? The four available response options were Always, Sometimes, Never and Missing. Percentages have been rounded off.
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) From Day 1 up to 30 days after last study dose (up to approximately 2 years) EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.
Change From Baseline Over Time in Symptoms as Assessed by EORTC-QLQ-C30 From Day 1 up to 30 days after last study dose (up to approximately 2 years) EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptoms items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30 From Day 1 up to 30 days after last study dose (up to approximately 2 years) EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), global health/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome.
Number of Participants With Ongoing Clinical Benefit After Cycle 16 (cycle length= 21 days) Number of Participants With Adverse Events (AEs) Up to approximately 2 years An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Number of Participants With AEs During Treatment Cross-over Period 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) An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. The safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC is being assessed in this outcome measure.
Trial Locations
- Locations (39)
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Instituto Europeo di Oncologia
🇮🇹Milano, Lombardia, Italy
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Hospital Universitario de Canarias;servicio de Oncologia
🇪🇸La Laguna, Tenerife, Spain
Tri County Hematologyoncology
🇺🇸Canton, Ohio, United States
UPMC - Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
ICIMED Instituto de Investigación en Ciencias Médicas
🇨🇷San José, Costa Rica
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
🇮🇹Roma, Lazio, Italy
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
🇪🇸A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron; Oncology
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
🇪🇸Zaragoza, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
Asante Rogue Regional Medical Center
🇺🇸Medford, Oregon, United States
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
🇧🇷Ijui, RS, Brazil
Fundación CENIT para la Investigación en Neurociencias
🇦🇷Buenos Aires, Argentina
OrlandiOncología
🇨🇱Santiago, Chile
James Lind Centro de Investigación Del Cáncer
🇨🇱Temuco, Chile
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Abruzzo, Italy
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
🇵🇱Otwock, Poland
Cemic; Oncologia Clinica
🇦🇷Buenos Aires, Argentina
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
🇨🇦Barrie, Ontario, Canada
Fundacion Arturo Lopez Perez; Quimioterapia
🇨🇱Providencia, Chile
Turun yliopistollinen keskussairaala (TYKS); Syöpäklinikka
🇫🇮Turku, Finland
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
🇫🇮Vaasa, Finland
Centro Oncologico Korben; Oncology
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, RS, Brazil
Tampereen yliopistollinen sairaala (TAYS); Syöpätautien poliklinikka
🇫🇮Tampere, Finland
Pauls Stradins Clinical University Hospital
🇱🇻R?ga, Latvia
New Jersey Hematology Oncology Associates LLC
🇺🇸Brick, New Jersey, United States
Hospital das Clinicas - UFRGS
🇧🇷Porto Alegre, RS, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, SP, Brazil
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Clinica CIMCA
🇨🇷San José, Costa Rica
Oulun yliopistollinen sairaala (OYS); Syöpätautien poliklinikka B
🇫🇮Oulu, Finland
A.O.U. Maggiore della Carità
🇮🇹Novara, Piemonte, Italy
Riga East Clinical University Hospital Latvian Oncology Centre
🇱🇻Riga, Latvia
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
🇵🇱Olsztyn, Poland
Sault Area Hospital
🇨🇦Sault Ste. Marie, Ontario, Canada