Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629027
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2020-11-06
Brief Title:
Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in NSCLC
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Establishment of a Comprehensive Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in the Treatment of Advanced Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
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:
Inhibitors of programmed cell death protein 1 PD-1 and programmed cell death ligand 1 PD-L1 are effective therapies for metastatic NSCLC lacking sensitizing EGFR or ALK mutations First-line combination regimens that include a PD-1 or PD-L1 inhibitor may maximize the chance of response and lead to prolonged survival PD-L1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment However it is far from being the ideal biomarker and its role in predicting efficacy from ICPIs remains undefined due to conflicting results from randomized clinical trials The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources Further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers Therefore our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors by combining the evaluation criteria of solid tumor efficacy evaluation criteria RECIST11 clinical pathological characteristics of patients and dynamic monitoring of peripheral blood molecular biological markers finding the correlation with the efficacy of immunotherapy establish a detection mode for selecting patients with clinical benefits
Detailed Description:
None
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