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Non-small-cell lung cancer (NSCLC) for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Led By Thomas Marron, MD, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Patient is determined to be a surgical candidate for resection of their tumor by a multidisciplinary team including a surgeon and a medical oncologist.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a combined treatment of two drugs, dupilumab and cemiplimab, for early-stage lung cancer patients. Participants will receive the drugs before surgery and will be monitored

Who is the study for?

This trial is for adults with early-stage, resectable non-small cell lung cancer (NSCLC). Candidates must have a confirmed NSCLC diagnosis or strong indications of NSCLC and be scheduled for biopsy. They should be able to undergo surgery, provide blood samples, and agree to use contraception. People who are pregnant, breastfeeding, or unable to consent are excluded.Check my eligibility

What is being tested?

The study tests neoadjuvant therapy using Dupilumab and Cemiplimab in patients with early-stage NSCLC before they undergo surgery. Participants will receive injections of Dupilumab and an IV of Cemiplimab followed by standard surgery within two weeks after treatment initiation.See study design

What are the potential side effects?

Potential side effects include allergic reactions at the injection site for Dupilumab, fatigue, skin issues like eczema flare-ups or rashes; while Cemiplimab may cause immune-related adverse effects such as inflammation in organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had a hysterectomy or both ovaries removed and have had a menstrual cycle in the past year.

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A team of doctors, including a surgeon and oncologist, has approved me for surgery to remove my tumor.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Frequency of dose limiting toxicities (DLTs)

Major pathological response (MPR)

Percentage of dose limiting toxicities (DLT)

Secondary outcome measures

Event-Free Survival (EFS)

Frequency of adverse events as measured in NCI CTCAE v5.0

Number of days leading to surgery

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non-small-cell lung cancer (NSCLC)Experimental Treatment2 Interventions

Participants will receive neoadjuvant subcutaneous Dupilumab 600mg and intravenous Cemiplimab 350mg on Day 1. Participants will proceed to standard of care surgery for early-stage, resectable NSCLC (within 7 days of Day 15), and will be observed for adverse events and dose limiting toxicities.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Dupilumab

2017

Completed Phase 4

~12230

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,605 Total Patients Enrolled

Thomas Marron, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for this research study still ongoing?

"Indeed, according to the details presented on clinicaltrials.gov, this specific clinical trial is presently in the recruitment phase. The initial posting of the trial occurred on January 1st, 2024 and it was most recently updated on January 9th, 2024."

Answered by AI

What is the uppermost limit for participant enrollment in this research endeavor?

"Indeed, the details listed on clinicaltrials.gov indicate that this particular clinical trial is actively seeking suitable candidates. The initial posting of the trial occurred on January 1st, 2024 and was most recently updated on January 9th, 2024. To complete the study, a total of 21 participants will be recruited from a single site."

Answered by AI

What are the primary goals of this particular investigation?

"The primary endpoint of this trial, assessed within approximately 30 days after treatment, is Major Pathological Response (MPR). Secondary outcomes include Event-Free Survival (EFS), which measures the time from initial administration of dupilumab and cemiplimab to disease progression, tumor recurrence post-surgery, or death from any cause regardless of origin. Additional secondary outcomes comprise Overall Survival (OS), defined as the duration between treatment initiation and patient mortality irrespective of etiology, as well as Number of Days Leading to Surgery, denoting the interval in days from the first dose of dupilumab until surgical intervention takes place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC

Thomas Marron 2024. "Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088771.