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Taxane
Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Megan Baumgart
Research Sponsored by University of Rochester
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 18 months
Awards & highlights
Study Summary
This trial is testing a new combination chemotherapy treatment for patients with lung cancer and limited activity.
Who is the study for?
This trial is for adults over 18 with advanced non-small cell lung cancer and an ECOG performance status of 2, meaning limited activity or significant rest needed. Eligible patients have specific blood count levels, can't be on high-dose steroids or other trials, and must not have severe untreated brain metastases or certain autoimmune diseases.Check my eligibility
What is being tested?
The study tests the combination of Pembrolizumab (an immune therapy) with a single chemotherapy agent (Pemetrexed or Nab-paclitaxel) in patients who are unsuitable for standard treatments. It aims to assess the tolerability and effectiveness of this regimen in those with reduced physical function.See study design
What are the potential side effects?
Possible side effects include reactions related to immune therapy such as fatigue, skin issues, inflammation of organs; chemotherapy may cause nausea, hair loss, low blood counts leading to increased infection risk. Specific effects depend on individual patient health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Percentage of participants with Complete Response or Partial Response
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental 2: pembrolizumab and Nab-paclitaxelExperimental Treatment2 Interventions
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days
Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone
Group II: Experimental 1: pembrolizumab and PemetrexedExperimental Treatment2 Interventions
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days
Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
842 Previous Clinical Trials
534,029 Total Patients Enrolled
Megan BaumgartPrincipal Investigator - University of Rochester
University of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can participate in the study even if you have small, symptom-free brain metastases.You have advanced stage cancer that has spread beyond its original location.You have not had a menstrual period for more than 2 years.You have heart, liver, or kidney problems that would make it unsafe to receive chemotherapy or immunotherapy, according to the doctor in charge of your treatment.You have a severe infection that needs to be treated with antibiotics through an IV.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental 1: pembrolizumab and Pemetrexed
- Group 2: Experimental 2: pembrolizumab and Nab-paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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