Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388031
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An exploratory phase II trial of immune checkpoint inhibitors ICIs anti-PD-1anti-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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None