← Back to Search

Monoclonal Antibodies

Dupilumab + Immunotherapy for Non-Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Thomas Marron, MD, PhD
Research Sponsored by Thomas Marron
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a pathologically confirmed diagnosis of NSCLC
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug for patients with relapsed or refractory lung cancer.

Who is the study for?
Adults over 18 with advanced NSCLC who've seen their cancer worsen after treatment with PD-1 or PD-L1 inhibitors can join. They must be able to provide blood samples, undergo biopsies, and use contraception if of childbearing potential. Exclusions include those with certain immune conditions, recent vaccines or chemotherapy, uncontrolled illnesses, pregnancy, specific drug allergies, organ transplants, and some infections.Check my eligibility
What is being tested?
The trial is testing Dupilumab in combination with a PD-1/PD-L1 inhibitor for patients whose NSCLC has relapsed or is refractory after previous treatments. It's a single-arm study aiming to see if blocking IL-4Ra alongside PD-(L)1 improves outcomes.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the protein-based therapy (Dupilumab), issues from immunosuppression like increased infection risk and possibly inflammation-related symptoms due to the immune system's heightened activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer diagnosis has been confirmed by a lab test.
Select...
I am 18 years old or older.
Select...
My cancer has worsened after treatment with a PD-1 or PD-L1 inhibitor.

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
Dose Limiting Toxicity (DLTs)
Overall Response Rate (ORR)
Secondary outcome measures
Best overall response (BORR)
Duration of response (DOR)
Overall Survival (OS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dupilumab + anti-PD-1/PD-L1 (SOC)Experimental Treatment2 Interventions
Patients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab will be administered
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved

Find a Location

Who is running the clinical trial?

Thomas MarronLead Sponsor
Thomas Marron, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05013450 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Dupilumab + anti-PD-1/PD-L1 (SOC)
Non-Small Cell Lung Cancer Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05013450 — Phase 1 & 2
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013450 — Phase 1 & 2

Frequently Asked Questions

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

What aims are the researchers seeking to accomplish with this experiment?

"The 9-week trial is intended to investigate Dose Limiting Toxicity (DLT). Secondary objectives include measuring Best overall response (BORR), Duration of response (DOR) and Overall Survival (OS). BORR will evaluate the percentage of patients showing partial or full remission within a year from initial therapy, whilst DOR corresponds to the time between PR/CR until documented progression. Finally, OS encompasses days from first dupilumab administration till death due to any cause."

Answered by AI

To what medical conditions does Dupilumab typically provide relief?

"Dupilumab is utilized to ameliorate symptoms of atopic dermatitis and has been seen as a successful adjunct treatment for corticosteroid failure, eosinophilia, and asthma."

Answered by AI

Are there any openings left in this research project for participants?

"The most current information available on clinicaltrials.gov details that enrollment for this medical trial is in progress. It initially began recruiting patients from September 10th 2021, and was last amended on November 22nd 2022."

Answered by AI

What is the sample size of individuals participating in this trial?

"Affirmative. Clinicaltrials.gov states that this clinical trial is currently searching for enrollees and was originally posted on September 10th 2021, with the latest update being November 22nd 2022. The medical study requires 21 participants from two sites to be recruited."

Answered by AI

Are there any other investigations which have focused on Dupilumab?

"As of now, Dupilumab is being studied in 49 active trials with 13 at the Phase 3 level. The majority are happening around Palo Alto but there are 2602 other sites conducting research as well."

Answered by AI

Is there any precedent to this particular research endeavor?

"Dupilumab's research timeline goes back to 2015, when Sanofi sponsored the first study on 880 patients. After this initial Phase 3 trial gained approval, 49 other studies have emerged across 436 cities and 43 nations."

Answered by AI

Who else is applying?

What site did they apply to?
The Blavatnik Family-Chelsea Medical Center at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Sep 2024