Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT06219317
Phase
PHASE2
Status
Recruiting
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Conditions

  • NSCLC Stage IV

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Cemiplimab is provided in a 10 ml glass vial
  • Placebo — DRUG
    standard saline solution

Study Details

This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment. Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.

Key Dates

Start date
Jan 14, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab
    Cemiplimab IV 350 mg every 3 weeks for up to 12 months or until progression or discontinuation
  • Placebo Comparator: Placebo
    Placebo (saline solution) IV every 3 weeks for up to 12 months or until progression or discontinuation

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 9 years from first patient randomized ]

Central Contacts

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