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Monoclonal Antibodies
Neoadjuvant Pembrolizumab for Non-Small Cell Lung Cancer (TOP 1501 Trial)
Phase 2
Waitlist Available
Led By Neal Ready, MD
Research Sponsored by Neal Ready
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed NSCLC
Patient must be deemed a surgical candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease recurrence or death (up to 5 years)
Awards & highlights
TOP 1501 Trial Summary
This trial is studying two doses of pembrolizumab given before and after surgery to see if it can shrink tumors in people with early-stage non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with stage IB-IIIA non-small cell lung cancer who haven't had prior treatments for it. They must be surgical candidates, not pregnant, and willing to undergo research blood sampling. Excluded are those with recent major surgery, other active cancers or serious illnesses, known infections like Hepatitis B/C or TB, autoimmune diseases treated in the last 2 years, heart issues within the past 6 months, or any condition that could affect study participation.Check my eligibility
What is being tested?
The trial tests pembrolizumab as an immunotherapy before and after surgery in patients with certain stages of lung cancer. It aims to see how this drug affects immune cells called TILs against cancer cells. Pembrolizumab is approved for advanced cases but its use here is investigational.See study design
What are the potential side effects?
Pembrolizumab may cause side effects such as immune-related inflammation of organs (like lungs), infusion reactions during administration, fatigue, skin rash or itching, liver enzyme changes indicating potential liver damage and can increase infection risk due to immune system alteration.
TOP 1501 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer diagnosis was confirmed through lab tests.
Select...
My doctor says I can have surgery.
Select...
My lung cancer is at a stage where surgery is possible.
Select...
I haven't received any treatment for my current lung cancer diagnosis.
Select...
I am 18 years old or older.
Select...
My lung function tests after surgery are expected to be above 40% of what's predicted.
Select...
My primary tumor is larger than 3 cm.
Select...
I am fully active or can carry out light work.
TOP 1501 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease recurrence or death (up to 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease recurrence or death (up to 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operative Surgical Procedures
Other outcome measures
Adverse Events
Change in Blood-based Biomarker Values
Change in Immunomodulatory Effects
+11 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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
TOP 1501 Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab prior to and after surgeryExperimental Treatment1 Intervention
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?
Neal ReadyLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,939 Total Patients Enrolled
Neal Ready, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is at a stage where surgery is possible.I have a history of lung scarring or fibrosis.I have an active tuberculosis infection.You are currently in prison or are being held against your will for treatment of a mental or physical illness.My lung cancer diagnosis was confirmed through lab tests.I have an autoimmune disease treated with medication in the last 2 years.My doctor says I can have surgery.My organs are functioning well.I have been diagnosed with HIV.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have another cancer that is getting worse or needs treatment.I haven't received any treatment for my current lung cancer diagnosis.I am 18 years old or older.I haven't had any cancer except for non-melanoma skin cancer in the last 2 years.My lung function tests after surgery are expected to be above 40% of what's predicted.I haven't had major surgery in the last 2 weeks and don't have serious health issues that would make the study unsafe for me.I have received vaccines for preventing infections.I have had a heart attack in the last 6 months or have uncontrolled heart issues.I haven't used any unapproved drugs or devices in the last 30 days.I have a history of or currently have non-infectious lung inflammation.I am not receiving any other cancer treatments.I have an active Hepatitis B or C infection.You are allergic to pembrolizumab or any of its ingredients.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am currently on medication for an active infection.My primary tumor is larger than 3 cm.I am fully active or can carry out light work.You have a disease that can be measured using specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab prior to and after surgery
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.
Could you please tell us about Pembrolizumab's clinical trial history?
"Out of the 1000 clinical trials utilising Pembrolizumab, 122 are currently in Phase 3. Though many of these studies originate from Houston, Texas; there are 36030 active locations for this treatment globally."
Answered by AI
What are Pembrolizumab's common therapeutic applications?
"Pembrolizumab is a medication that oncologists often use to treat cancer. Additionally, it can be useful for patients with microsatellite instability high or those who have experienced disease progression after chemotherapy."
Answered by AI
Are we looking for more test subjects at this time?
"Unfortunately, this particular clinical trial is not taking any more patients at the moment. Although, there are 2394 other trials that might be of interest and are currently recruiting participants."
Answered by AI
How many test subjects are involved in this clinical trial?
"Unfortunately, this study is no longer seeking participants. If you were hoping to enroll in this trial, we encourage you to explore the other 1,394 trials actively recruiting patients with carcinoma or non-small-cell lung cancer."
Answered by AI
What are some possible side effects of Pembrolizumab?
"While there is some evidence of safety, as this is a Phase 2 trial, Power rates the safety of Pembrolizumab at a 2."
Answered by AI
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