RecruitingPhase 2NCT06388031

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


Sponsor

Peking Union Medical College Hospital

Enrollment

27 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether re-starting immunotherapy (checkpoint inhibitors like pembrolizumab or nivolumab) helps patients with advanced non-small cell lung cancer (NSCLC) who had a long response to their first course of immunotherapy but have since progressed. **You may be eligible if...** - You are between 18 and 80 years old with confirmed stage III or IV non-small cell lung cancer - You completed at least 35 cycles of first-line immunotherapy (with or without chemotherapy) or had stable disease for at least 2 years — and have now progressed - You have at least one measurable tumor on scans - Your general health score (ECOG) is 0–2 **You may NOT be eligible if...** - Your cancer has a treatable mutation (like EGFR, ALK, ROS1) that has specific targeted therapy options - You had serious immune-related side effects from prior immunotherapy - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImmune 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.


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT06388031


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