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Dupilumab + Immunotherapy for Non-Small Cell Lung Cancer
Study Summary
This trial is testing the safety and effectiveness of a new drug for patients with relapsed or refractory lung cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I do not have any severe illnesses that could interfere with the study.You have had a bad reaction to any protein-based medications. The principal investigator thinks you might not be able to attend all the study visits or that the trial might not be good for your health.I am not on high-dose steroids or immunosuppressants, or have been for over 4 weeks on a low dose (≤10mg prednisone).I have active Hepatitis B or C, or I'm controlling it with treatment.I can care for myself despite any long-term disabilities I may have.My lung cancer diagnosis has been confirmed by a lab test.I have not received a live vaccine in the last 30 days.I have had side effects from previous immunotherapy that haven't fully improved.I agree to use birth control during and for 3 months after the study if I can have children.I am 18 years old or older.I am willing to undergo several biopsies before and during my treatment.I have a history of lung conditions or inflammation from cancer treatment, but not from radiation.I have an autoimmune disease but only take replacement therapy like insulin.My cancer has worsened after treatment with a PD-1 or PD-L1 inhibitor.You have HIV and your viral load is not well controlled, or you are not taking consistent medication for HIV, or your CD4+ T cell count is below 350.I have had a bone marrow or organ transplant.I have not had chemotherapy in the last 14 days.I have had at most one treatment since my last PD-(L)1 therapy.
- Group 1: Dupilumab + anti-PD-1/PD-L1 (SOC)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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What portion of applicants met pre-screening criteria?
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