Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC

Sponsor
The Netherlands Cancer Institute
Study ID
NCT05401786
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Anti-CTLA-4
  • Cemiplimab — DRUG
    PD-1 inhibition
  • SBRT — RADIATION
    Stereotactic Body Radiotherapy

Study Details

Still many advanced non-small cell lung cancer (NSCLC) patients do not benefit from PD-(L)1 inhibition or will eventually develop progression through secondary resistance. Inhibition of CTLA-4, application of radiotherapy together with PD-1 inhibition showed synergistic effects and is deemed safe.

Key Dates

Start date
Jan 3, 2023
Status verified
Mar 2026
Primary completion
Nov 15, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-CTLA-4, SBRT and PD1
    Participants will receive 1 dose of ipilimumab (1mg/kg intravenously) on day 1. After 1 week the participants will receive SBRT (3x8Gy) on at least 1 but no more than 4 tumor lesions. Within 1 week of the last radiation fraction participants will start with cemiplimab (350mg intravenously every 3 weeks) until disease progression, unacceptable toxicity, patient request for discontinuation, or up to 2 years of treatment

Primary Outcome Measure

Clinical Benefit Rate [ Time Frame: Through study completion, an average of 1 year ]

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