Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-04 @ 1:46 PM
Study NCT ID:
NCT02934503
Status:
TERMINATED
Last Update Posted:
2021-11-16
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC)
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
A Phase II Study of Pembrolizumab and Dynamic PD-L1 Expression in Extensive Stage Small Cell Lung Cancer (SCLC)
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated as the standard of care for small cell lung cancer changed in 2018 to include immunotherapy in the front line setting, making this study no longer clinically relevant.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with or without radiation therapy in patients with small cell lung cancer (SCLC).
Detailed Description:
SCLC provides an opportune setting to evaluate the potential importance of variability in PD-L1 expression and its influence on optimizing timing and efficacy of checkpoint inhibition. All extensive stage SCLC patients are treated with chemotherapy and recent data suggests added benefit to consolidation thoracic radiation. A prior study of patients with known PD-L1 expression showed a 35% response rate. That study used archival specimens and found a 29% PD-L1 positivity rate (at 1% level) suggesting that the expression level and prevalence could be higher (and response rate/outcome therefore potentially better) in patients who have previously had chemotherapy or radiation. The proposed study seeks to evaluate pembrolizumab therapy initiated at different times during the course of SCLC treatment: a) up front, in conjunction with initiation of chemotherapy, b) starting after one cycle of chemotherapy, c) starting after completion of 1st line chemotherapy (4-6 cycles), d) starting after completion of consolidation thoracic radiation therapy and/or prophylactic cranial irradiation (PCI). Treatment with pembrolizumab will be preceded by biopsy for evaluation of PD-L1 expression with correlative evaluation of changes in PD-L1 expression (relative to diagnostic biopsy) and changes in other tissue- and blood-based biomarkers and immune markers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: