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

NCT06388031 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-11-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Minjiang Chen, MD. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2027-01-10
Completion
2027-12-10

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388031 on ClinicalTrials.gov