Sequencing of Stereotactic Ablative Body Radiotherapy in Combination With PD-1 Blockade Using Pembrolizumab in Metastatic Non-Small Cell Lung Carcinoma

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT03307759
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab
  • Radiotherapy (SABR) — RADIATION
    Radiotherapy

Study Details

This investigator driven Phase Ib study will examine the safety, efficacy and biological effects of two schedules of pembrolizumab, an antibody targeted against anti-programmed cell death 1 (PD-1), which will be given either before or after stereotactic ablative body radiotherapy (SABR) for metastatic NSCLC.

Key Dates

Start date
Dec 7, 2017
Status verified
Aug 2025
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SABR plus pembrolizumab
    SABR followed by pembrolizumab
  • Active Comparator: Pembrolizumab plus SABR
    Pembrolizumab followed by SABR after cycle 1

Primary Outcome Measure

Adverse Events Measured Using CTCAE Version 4.03 [ Time Frame: Up to 24 months after commencement of treatment ]

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