Phase 2
Completed N=179
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
Source: ClinicalTrials.gov NCT05171777 ↗Enrolled (actual)
179
Serious AEs
15.0%
Results posted
Nov 2024
Primary outcomePrimary: Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) — 71.67; 69.84; 70.73 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) |
71.67; 69.84; 70.73 | — |
| SECONDARY 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) |
25; 10; 31; 34; 17; 11 | — |
| SECONDARY Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period |
78.2; 76.7 | — |
| SECONDARY 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 |
5.0; 5.0; 5.0; 5.0; 5.0; 4.5 | — |
| SECONDARY 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 |
7.0; 10.0; 7.0; 0; 21.1; 31.7 | — |
| SECONDARY 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 |
71.9; 58.3; 0; 0; 17.5; 21.7 | — |
| SECONDARY Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room |
5; 30.0; 5.0; 60.0; 8.0; 92.0 | — |
| SECONDARY 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 |
13.8; 11.5; 15.5; 23.0; 1.7; 6.6 | — |
| SECONDARY 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 |
72.4; 63.9; 5.2; 10.1; 6.9; 8.4 | — |
| SECONDARY 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 |
41.4; 31.1; 34.5; 37.7; 10.3; 14.8 | — |
| SECONDARY Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) |
75.00; 72.09; -0.46; -2.01; 0.00; -1.60 | — |
| SECONDARY Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30 |
77.46; 73.73; 1.16; -1.33; -2.01; -1.64 | — |
| SECONDARY Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30 |
79.48; 75.98; 2.62; 0.89; 0.77; 4.10 | — |
| SECONDARY Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30 |
87.31; 85.69; 2.31; -5.56; -5.75; -1.09 | — |
| SECONDARY Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30 |
82.95; 82.35; 3.70; -3.56; -2.87; -1.91 | — |
| SECONDARY Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30 |
30.81; 36.08; 0.15; -1.63; 4.41; 1.46 | — |
| SECONDARY Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30 |
5.30; 5.88; 2.31; 1.56; 2.01; 3.01 | — |
| SECONDARY Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30 |
22.16; 29.22; 0.93; -3.56; 4.02; -1.09 | — |
| SECONDARY Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30 |
25.38; 30.59; 5.09; 0.89; -0.57; -2.73 | — |
| SECONDARY Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30 |
23.11; 28.63; 0.46; -0.44; 0.57; 2.19 | — |
| SECONDARY Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30 |
16.67; 21.96; 2.31; 2.22; 2.87; -2.19 | — |
| SECONDARY Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30 |
19.32; 21.96; 0.00; -2.67; -4.60; -3.28 | — |
| SECONDARY Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30 |
5.68; 7.06; 0.93; 2.22; -2.30; 3.28 | — |
| SECONDARY Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30 |
13.79; 20.39; 7.98; -1.33; 11.11; 0.00 | — |
| SECONDARY Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30 |
67.05; 64.80; 0.12; -0.22; -2.49; -0.27 | — |
| SECONDARY Percentage of Participants With Ongoing Clinical Benefit |
44.7 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
59.4; 47.7; 76.9; 67.4 | — |
| SECONDARY Percentage of Participants With AEs During Treatment Cross-over Period |
62.9; 39.1; 54.7; 53.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT05171777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.