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New treatment option for Non-Small Cell Lung Cancer
Official title Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
ClinicalTrials.gov ID: NCT06088771
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Dupixent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological diagnosis of NSCLC is required before initiation of treatment, however, patients who have a smoking history and radiographic findings...
- Patient must be willing and able to provide blood samples (6 heparinized tubes, 2 streck tubes, roughly 60mL) at the time points indicated in the...
- Patient must be willing and able to have core needle biopsies (Goal 3-6 biopsies, final number to be determined by the surgeon and radiologist...
- Age ≥ 18 years.
- ECOG 0-1. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive...
You likely can't join if
- Patients with history of autoimmune disorder or any patient who has used an immunomodulatory drug, such as dupilumab, within 8 weeks of starting...
- Patients without any smoking history, or any patient for whom we already have tissue or ctDNA evidence of an activating EGFR mutation or an ALK or...
- Patients who have had chemotherapy or radiotherapy within 4 months prior to entering the study for a different primary tumor, nor can they have...
- Patients may not be receiving any other investigational agents.
- Patients with metastatic disease, for whom the intent of surgery would not be curative.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days)...
See the full eligibility criteria
Who can join
- Histological diagnosis of NSCLC is required before initiation of treatment, however, patients who have a smoking history and radiographic findings highly suggestive of a diagnosis of NSCLC who are scheduled to undergo...
- Patient must be willing and able to provide blood samples (6 heparinized tubes, 2 streck tubes, roughly 60mL) at the time points indicated in the Study Calendar.
- Patient must be willing and able to have core needle biopsies (Goal 3-6 biopsies, final number to be determined by the surgeon and radiologist performing the procedure as safe) of tumor prior to initiation of therapy.
- Age ≥ 18 years.
- ECOG 0-1. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy.
- Patient is determined to be a surgical candidate for resection of their tumor by a multidisciplinary team including a surgeon and a medical oncologist.
- Women of child-bearing potential and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy Should a woman become...
- 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).
- Ability to understand and the willingness to sign a written informed consent.
- Adequate organ and marrow function as defined below:
- System/Laboratory Value
- Hematologic: Absolute neutrophil count (ANC) ≥1,000 /mcL Platelets ≥75,000 /mcL Hemoglobin ≥9 g/dL
- Renal\ Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for patient with creatinine levels \> 1.5 X...
- Hepatic\ Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN AST and ALT ≤ 2.5 X ULN Albumin \>2.5 mg/dL
- Coagulation\ International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
- If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause...
What rules you out
- Patients with history of autoimmune disorder or any patient who has used an immunomodulatory drug, such as dupilumab, within 8 weeks of starting treatment.
- Patients without any smoking history, or any patient for whom we already have tissue or ctDNA evidence of an activating EGFR mutation or an ALK or ROS1 rearrangement.
- Patients who have had chemotherapy or radiotherapy within 4 months prior to entering the study for a different primary tumor, nor can they have received locoregional therapy (e.g. radiation) for the target lesion that...
- Patients may not be receiving any other investigational agents.
- Patients with metastatic disease, for whom the intent of surgery would not be curative.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment)...
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Use of another immunomodulatory drug, including dupilumab, that may confound interpretation of clinical and biospecimen analysis, within 8 weeks of enrollment.
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the administration of trial treatment. Patients on chronic...
- Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine...
- Has a known additional malignancy that is progressing and requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is...
- HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen.
- Has known active Hepatitis B (e.g., HBV detected by PCR (\>200 IU/ml) or active Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Patients whom have recently started (\>14d from C1D1) antiviral therapy may go on to the trial.
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
- Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)
- Principle investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.
- Any evidence of current ILD or pneumonitis or a prior history of ILD or pneumonitis requiring oral or IV glucocorticoids.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.