NCT05401786

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The aim of this study is to investigate whether the combining of T cell priming by CTLA-4 inhibition (ipilimumab) ad subsequent immune boosting by stereotactic body radiotherapy (SBRT) on 1-4 tumor lesions can re-invigorate the response on PD-1 inhibition (cemiplimab) after initial non-response or secondary resistance to anti-PD-(L)1 treatment. Elaborate translational research by repeat biopsies in combination with blood collection during the different stages of treatment will help improve understanding of the joint effort of these different interventions.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Ipilimumab	Anti-CTLA-4
DRUG	Cemiplimab	PD-1 inhibition
RADIATION	SBRT	Stereotactic Body Radiotherapy

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-11-15
• Completion: 2026-06-01
• First posted: 2022-06-02
• Last updated: 2026-03-12

Locations

1 site across 1 country: Netherlands