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
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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