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Pembrolizumab for Recurrent Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Abigail Berman, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic or cytologic diagnosis of NSCLC who have received previous intrathoracic radiation therapy with definitive intent and have a tumor recurrence in or near the prior irradiation fields. Re-biopsy of the recurrence is not required and is left to the discretion of the treating physician, although every effort should be made to confirm recurrence pathologically.
Clinical target volume (CTV) size must be <250 cc, no more than 74 Gy of prior radiation in 2 Gy fractions previously administered.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating NSCLC that has returned after radiation therapy.

Who is the study for?
This trial is for adults with NSCLC who've had radiation before and now have a tumor recurrence. They must be in good health, with proper liver and kidney function, no active diseases requiring treatment in the past 2 years, and an ECOG status of 0-1. Excluded are those with certain lung conditions, hepatitis B or C, recent radiation therapy within 6 months to the treatment area, oxygen dependency, progression on similar cancer drugs before, allergies to Pembrolizumab compounds or severe autoimmune disease.Check my eligibility
What is being tested?
The study tests pembrolizumab's safety and effectiveness for NSCLC recurrences post-radiation therapy. Participants will receive this experimental drug to see how well it works against their cancer that has returned after previous treatments.See study design
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs like lungs (pneumonitis), liver inflammation (hepatitis), skin rashes; it can also lead to fatigue, infusion-related reactions such as fever or chills, digestive issues including diarrhea or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have lung cancer and have had radiation treatment in the chest area before. If the cancer comes back in or near the same area, you may not need another biopsy, but your doctor will decide.
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The size of the treatment area must be less than 250 cc, and you have not received more than 74 Gy of radiation in the past.
Select...
You are able to perform daily activities without any difficulty or with slight restriction.
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You had cancer before, but it was treated and there is no sign of it coming back in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Number of Subjects With Progression Free Survival
Secondary outcome measures
Number of Participants Who Experienced a Grade 3+ Adverse Event

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Single Arm, Open Label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,109 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
383 Previous Clinical Trials
144,865 Total Patients Enrolled
Abigail Berman, MDPrincipal InvestigatorAbramson Cancer Center of the University of Pennsylvania
2 Previous Clinical Trials
73 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03087760 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Single Arm
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03087760 — Phase 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03087760 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab undergone the FDA's approval process?

"While there is some data indicating that Pembrolizumab is safe, it did not receive a higher score because there is no evidence yet of the efficacy."

Answered by AI

What other similar tests has Pembrolizumab been a part of in the past?

"Pembrolizumab is being studied in 1000 different clinical trials, 122 of which are currently active. Of the active trials, many are based in Houston but there are 36034 total locations for these medical studies."

Answered by AI

Does this study have open enrollment at the moment?

"Currently, this clinical trial is not enrolling patients. This study was first posted on January 18th, 2017 and was last edited on November 1st, 2022. However, there are 3038 other trials related to lung cancer currently recruiting participants and 1000 studies involving Pembrolizumab that are actively admitting patients."

Answered by AI

What are the most common illnesses that Pembrolizumab is prescribed for?

"Pembrolizumab can be used to target and treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI
~4 spots leftby Mar 2025