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Phase 2 Completed N=179 Randomized Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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