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PD-1 Inhibitor
Pembrolizumab for Advanced Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Deborah Doroshow, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists
Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent chemoradiation, or metastatic NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial will investigate the effect of PD-1 therapy on quality of life in advanced NSCLC patients ineligible for curative treatment.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) who can't have surgery or intense treatment, and haven't had systemic therapy for metastatic cancer. They must have a certain level of tumor protein (PDL-1 TPS ≥ 1%) and be physically able to take part in the study despite having an ECOG performance status of 2 or 3. Participants need functioning organs, controlled HIV if present, no recent brain metastases needing immediate treatment, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab, an anti PD-1 therapy given intravenously every three weeks to patients with NSCLC. The main goal is to see how it affects quality of life over time using the QLQ-C30 questionnaire. Secondary goals include checking mental health changes and disease response through PET/CT scans following RECIST criteria.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), fatigue, infusion reactions during administration of the drug, and possibly increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer does not have genetic changes targeted by FDA-approved drugs.
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I am 18 or older with advanced or metastatic non-small cell lung cancer not eligible for surgery or chemoradiation.
Select...
My blood and organ tests show I am healthy enough for the trial.
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I have never been treated with PD-1 or PD-L1 inhibitors.
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I can walk and take care of myself but not able to work.
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I have not had any drug treatments for cancer that has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Glycation End Products, Advanced
Change in EORTC QLQ-C30 Quality of Life score
Change in EORTC's QLQ-LC13 Quality of Life (QOL) score
+10 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Patients will be treated with the standard dose of pembrolizumab (200mg IV every 3 weeks) for the first 12 weeks of the study. After week 12 assessments, patients without objective progression of disease are eligible to transition to Q6W dosing of pembrolizumab 400mg IV.
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?
Icahn School of Medicine at Mount SinaiLead Sponsor
868 Previous Clinical Trials
527,082 Total Patients Enrolled
Deborah Doroshow, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
24 Total Patients Enrolled
Bailey Fitzgerald, MDStudy DirectorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have a recent negative pregnancy test.I am HIV positive, on treatment, and my viral load is undetectable.My doctor says I don't need immediate brain treatment for my cancer.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I can take the study medication and fill out the study questionnaires.My cancer does not have genetic changes targeted by FDA-approved drugs.I need treatment for cancer that has spread to the lining of my brain and spinal cord.I am 18 or older with advanced or metastatic non-small cell lung cancer not eligible for surgery or chemoradiation.My blood and organ tests show I am healthy enough for the trial.My brain cancer has not worsened 4 weeks after treatment.I agree to use effective birth control methods if I am a man who can father a child.I take more than 10mg of prednisone daily for an autoimmune condition.You are currently taking other experimental drugs for a different study.I have never been treated with PD-1 or PD-L1 inhibitors.I can walk and take care of myself but not able to work.I have not had any drug treatments for cancer that has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
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.
How have the safety outcomes been for patients taking Pembrolizumab?
"Although there is evidence of Pembrolizumab's safety, its efficacy has yet to be established. Accordingly, the drug received a score of 2 on our team's scale from 1 to 3."
Answered by AI
Is this medical study open to participants at the moment?
"This scientific endeavour, which was initially advertised on November 1st of 2022, is not presently seeking applicants. Nevertheless, there are 1527 other medical studies that require participants at the present moment."
Answered by AI
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