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Alkylating agents

Pembrolizumab for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By William J Petty, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of time from randomization to the time of immune-related progressive disease or death, whichever comes first, assessed up to 3 years
Awards & highlights

Study Summary

This trial is studying pembrolizumab with or without carboplatin and paclitaxel to see if it can improve immune responses in patients with non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of time from randomization to the time of immune-related progressive disease or death, whichever comes first, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of time from randomization to the time of immune-related progressive disease or death, whichever comes first, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
Duration of Response
Objective Response Rate (ORR), Assessed Using RECIST
+2 more
Secondary outcome measures
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
Number of Participants With Reported Adverse Events - CTCAE Version 4.0

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (pembrolizumab, paclitaxel, carboplatin)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (pembrolizumab)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,140 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,110 Total Patients Enrolled
William J Petty, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02581943 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
2016. "Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02581943.
~5 spots leftby Apr 2025
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