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Checkpoint Inhibitor
Interleukin-2 + Pembrolizumab for Lung Cancer
Phase < 1
Recruiting
Led By Suresh S Ramalingam, MD, FACP, FASCO
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have Stage IV non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma
Patients must have adequate organ and marrow function including specific blood counts, liver function, and kidney function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year, 3 year, and 5 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat previously untreated stage IV non-small cell lung cancer. The drugs are interleukin-2 and pembrolizumab.
Who is the study for?
Adults over 18 with Stage IV non-small cell lung cancer (NSCLC) who haven't had prior treatments for advanced NSCLC can join. They need good organ function, measurable disease by RECIST criteria, life expectancy over 12 weeks, and some PD-L1 expression in tumors. Brain metastasis is okay if stable or symptom-free. Must not be pregnant and agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests a combination of low-dose interleukin-2 (IL-2) and pembrolizumab on patients with untreated stage IV NSCLC. It aims to see if this combo reactivates T cells against the tumor better than previous methods, checking both immune response and clinical outcomes.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, flu-like symptoms due to IL-2; pembrolizumab may cause similar issues plus potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Stage IV non-small cell lung cancer.
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My blood, liver, and kidney functions are all within normal ranges.
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I have not received any treatment for advanced non-small cell lung cancer.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 1 year, 3 year, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year, 3 year, and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune Response To Combination IL-2 and Pembrolizumab
Secondary outcome measures
Mutagenicity Tests
Incidence of Adverse Events (AEs)
Objective Response Rate
+2 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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, aldesleukin)Experimental Treatment2 Interventions
Patients will be treated with pembrolizumab 200 mg IV once every 3 weeks in combination with IL-2 given at 5 million IU subcutaneously twice daily for 3 weeks (5 days on, 2 days off each week, first dose in clinic and subsequent doses at home). IL-2 will be given only for the three weeks, after which pembrolizumab will be continued as monotherapy at either 200 mg every 3 weeks or 400 mg every 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,681 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,839 Total Patients Enrolled
Suresh S Ramalingam, MD, FACP, FASCOPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had serious allergic reactions to certain types of medications in the past.I am currently being treated for another cancer.I have Stage IV non-small cell lung cancer.Patients must have a way to measure their disease that follows specific guidelines.I have active tuberculosis.Women who could become pregnant need to have a negative pregnancy test within 14 days before starting the study treatment.I have not had a severe infection in the last 4 weeks.I have not received a live flu vaccine within the last 4 weeks.I am HIV positive.I have received chemotherapy or immunotherapy for advanced lung cancer.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I haven't taken any immune-weakening medications in the last 2 weeks.My cancer has a specific genetic change that can be targeted with treatment.Your heart's electrical activity, measured by EKG, takes longer than it should.I have previously been treated with anti-PD-1 or anti-PD-L1 therapies.My blood, liver, and kidney functions are all within normal ranges.You have signs of a serious problem in your internal organs.I have not received any treatment for advanced non-small cell lung cancer.I have not had major surgery in the last 28 days.I am 18 years old or older.You have a history of autoimmune disease or are at risk of developing one.You have had a bone marrow or solid organ transplant in the past.My tumor shows PD-L1 expression of 1% or more, or its PD-L1 status is unknown.You are expected to live for at least 12 more weeks.I have a significant liver condition, such as hepatitis or cirrhosis.I am able to care for myself and perform daily activities.My brain metastasis is stable or doesn't cause symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, aldesleukin)
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.
Is this clinical exploration still recruiting participants?
"The data reported on clinicaltrials.gov reveal that this medical experiment is currently not seeking participants, despite having been initially posted in December 1st 2022 and last updated October 3rd of the same year. Nonetheless, 2048 other trials are open for enrolment presently."
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