Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced Oligoprogressive NSCLC

Phase 2

Active, not recruiting

• Conditions: NSCLC Stage IV
• Interventions: Drug: Atezolizumab

• Registration Number: NCT04549428
• Lead Sponsor: Oncology Institute of Southern Switzerland

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.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Study Start: 2020-10-01
• Primary Completion: 2023-01-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atezolizumab	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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	3 months	Percentage of patients with a complete response or partial response

Secondary Outcome Measures

Name	Time	Method
Progression Free-Survival	12 months	Time in months from the first day of study treatment until the first evidence of tumour progression
Overall Survival	12 months	Time in months from the first day of study treatment to the date of death

Trial Locations

Locations (3)

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Cantonal Hospital of Graubünden (KSGR); 🇨🇭 Chur, Switzerland

Geneva University Hospitals (HUG); 🇨🇭 Geneva, Switzerland