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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Atezolizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Participants will receive atezolizumab SC followed by atezolizumab IV. | Drug: Atezolizumab<br>* 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.<br>* Other names: Tecentriq;|
| Experimental: Treatment B<br>Participants will receive atezolizumab IV followed by atezolizumab SC. | Drug: Atezolizumab<br>* 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.<br>* Other names: Tecentriq;|

What is the study measuring?
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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) |