Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754815
Status:
WITHDRAWN
Last Update Posted:
2022-03-29
First Post:
2021-02-10
Brief Title:
Study of Pembrolizumab With Single Agent Chemotherapy in Elderly Patients With Advanced NSCLC
Sponsor:
Shirish Gadgeel
Organization:
Henry Ford Health System
Study Overview
Official Title:
Phase II Study of Pemetrexed or Nab-paclitaxel With Pembrolizumab in Elderly 75 Years Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Logistical challenges primarily due to COVID led to delay in starting the study and now is not felt to be clinically relevant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HFHS 21-01
Brief Summary:
This Phase II trial is to see how well single agent chemotherapy and pembrolizumab work elderly patients 75 years with advanced non small cell lung cancer NSCLC Pembrolizumab stimulates your immune system to help fight lung cancer This treatment approach may be better tolerated in elderly patients
Detailed Description:
Primary Objectives Hypothesises and Endpoints
I Objective To evaluate the efficacy of single agent chemotherapy and pembrolizumab in elderly 75 years advanced NSCLC patients Hypothesis We propose that single agent chemotherapy with pembrolizumab will be better tolerated and will provide similar efficacy as platinum-based combination chemotherapy with pembrolizumab in advanced elderly 75 years NSCLC patients
Primary Endpoint
I Assess median PFS in elderly 75 years advanced NSCLC patients with tumor PD-L1 50 treated with pemetrexed or nab-paclitaxel and pembrolizumab
Secondary Objectives Hypothesises and Endpoints
I Objective To assess additional measure of efficacy of the regimen To define the toxicity of the regimen in addition
II Hypothesis In this patient population single agent chemotherapy and pembrolizumab will provide similar efficacy but improved tolerability as 2 drug combination with pembrolizumab
Secondary Endpoints
I Assess overall survival in the study population II Assess the toxicities with the study therapy and the rate of discontinuation of study therapy due to toxicities related to study therapy
Exploratory Objective
I Objective To define correlatives that can identify patients most likely to benefit from the study therapy
II Correlate PFS with blood-based tumor mutational burden and ctDNA
Participants who experience confirmed disease progression or start a new anticancer therapy will move into the Survival Follow-Up Phase and should be contacted by telephone every 12 weeks to assess for survival status until death withdrawal of consent or the end of the trial whichever occurs first
I Objective To evaluate the efficacy of single agent chemotherapy and pembrolizumab in elderly 75 years advanced NSCLC patients Hypothesis We propose that single agent chemotherapy with pembrolizumab will be better tolerated and will provide similar efficacy as platinum-based combination chemotherapy with pembrolizumab in advanced elderly 75 years NSCLC patients
Primary Endpoint
I Assess median PFS in elderly 75 years advanced NSCLC patients with tumor PD-L1 50 treated with pemetrexed or nab-paclitaxel and pembrolizumab
Secondary Objectives Hypothesises and Endpoints
I Objective To assess additional measure of efficacy of the regimen To define the toxicity of the regimen in addition
II Hypothesis In this patient population single agent chemotherapy and pembrolizumab will provide similar efficacy but improved tolerability as 2 drug combination with pembrolizumab
Secondary Endpoints
I Assess overall survival in the study population II Assess the toxicities with the study therapy and the rate of discontinuation of study therapy due to toxicities related to study therapy
Exploratory Objective
I Objective To define correlatives that can identify patients most likely to benefit from the study therapy
II Correlate PFS with blood-based tumor mutational burden and ctDNA
Participants who experience confirmed disease progression or start a new anticancer therapy will move into the Survival Follow-Up Phase and should be contacted by telephone every 12 weeks to assess for survival status until death withdrawal of consent or the end of the trial whichever occurs first
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None