Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced, Oligoprogressive NSCLC After Upfront Chemotherapy and Anti-PD1 Immunotherapy: A Multicentre, Single Arm, Phase II Study
Overview
- Phase
- Phase 2
- Intervention
- Atezolizumab
- Conditions
- NSCLC Stage IV
- Sponsor
- Oncology Institute of Southern Switzerland
- Enrollment
- 12
- Locations
- 3
- Primary Endpoint
- Objective Response Rate
- Status
- Terminated
- Last Updated
- 5 months ago
Overview
Brief Summary
Multicentre, phase II, open-label, single-arm study evaluating the preliminary efficacy, safety and tolerability of atezolizumab in association with palliative radiotherapy in adult patients diagnosed with advanced (stage IV) NSCLC, irrespective of PD-L1 status, and who have oligoprogressed to both immunotherapy with an anti PD-1 agent (e.g., pembrolizumab or nivolumab) and 1 line of chemotherapy.
Detailed Description
Atezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy to all eligible metastatic and primary sites.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Atezolizumab
Atezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis until progression, intolerance or loss of clinical benefit, according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy
Intervention: Atezolizumab
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 3 months
Percentage of patients with a complete response or partial response
Secondary Outcomes
- Progression Free-Survival(12 months)
- Overall Survival(12 months)