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

Sponsor
Oncology Institute of Southern Switzerland
Study ID
NCT04549428
Phase
PHASE2
Status
Terminated

Conditions

  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Intravenous infusion every 21 days, until disease progression, intolerance or loss of clinical benefit.

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Nov 2025
Primary completion
Jan 23, 2023
Completion
May 31, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

Objective Response Rate [ Time Frame: 3 months ]

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