NCT06388031

ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI

A Multicenter, Single-Arm Pilot Study of Immune Checkpoint Inhibitors in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Who Had Long-Term (Two Years or Longer) Response to First-Line Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy). This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis.

Detailed description

This is a multi-center study. The study plans to include a total of 27 advanced NSCLCs who had benefited from first-line immunotherapy over two years before disease progression. Participants will receive up to 17 cycles of ICI (anti-PD-1 or anti-PD-L1) monotherapy. Optional ICI monotherapy regimens include: Pembrolizumab 200mg every 3 weeks, or Tislelizumab 200mg every 3 weeks, or Camrelizumab 200mg every 3 weeks, or Toripalimab 240mg every 3 weeks. The outcomes including efficacy and safety will be examined. Additionally, peripheral blood samples will be collected before treatment, and at the 6th, 12th, and 24th weeks after treatment initiation to explore biomarkers for immunotherapy. Also it is highly recommended to collect pretreatment tumor tissue from patients.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Immune checkpoint inhibitor	Physician's choice immunotherapy with one of the following every 21 days until disease progression or intolerable toxicity or up to 17 cycles: * Pembrolizumab 200mg; * Tislelizumab 200mg; * Camrelizumab 200mg; * Toripalimab 240mg.

Timeline

• Start date: 2024-08-09
• Primary completion: 2027-01-10
• Completion: 2027-12-10
• First posted: 2024-04-29
• Last updated: 2024-11-07

Locations

1 site across 1 country: China