Metastatic Non-small Cell Lung CancerPhase 1/2NCT05013450
Dupilumab_Metastatic NSCLC
A Phase 1/2 study testing Dupilumab, PD-1/PD-L1 blockade and Anakinra in people with Metastatic Non-small Cell Lung Cancer, run by Thomas Marron at 1 site in United States.
Trial summary
This is a multi cohort, sequential enrollment clinical trial to determine the safety and tolerability of Dupilumab and Anakinra with PD-(L)1 blockade for patients with relapsed/refractory metastatic NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Dupilumab, PD-1/PD-L1 blockade and Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 18 Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a pathologically confirmed diagnosis of NSCLC
- Patients must have progressed (clinically or radiographically) on or following prior therapy with a PD-1 or PD-L1 targeted antibody
- Patients may have only 0 or 1 intervening lines of therapy from the prior PD-(L)1 blocking therapy
- Patient must be willing and able to provide blood samples (12 green-top tubes, roughly 100mL) at the time points indicated in the Study Calendar.
- Patient must be willing and able to have core needle biopsies, or forceps biopsies if clinically feasible by (Goal 3-6 biopsies, final number to be determined by the interventionalist performing the procedure as safe) of tumor prior to initiation of dupilumab and at the on-treatment time point. Should patients undergo pre-treatment or on-treatment biopsy procedure, and inadequate number of biopsies are obtained, they may proceed with initiation/continuation of treatment at the discretion of the investigator and treating physician
- Age ≥ 18 years.
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- ECOG 0-2. 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.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients who have had chemotherapy within 14 days from start of therapy.
- Palliative radiotherapy is permitted at any time, if deemed in the best interest of the patient.
- 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), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
- 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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
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- 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 not in the best interest of the patient to participate, in the opinion of the treating Investigator.
- HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with <350 CD4+ T cells/microliter in the peripheral blood. HIV testing is not required for patients with no known history of HIV.
- Has known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
- Receipt of a live vaccine within 30 days of planned start of study medication
- 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.
- History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy
- History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted.
- Patient has received Anakinra in the last 12 months (Cohort B).
Trial locations and contacts
1 site in 1 country.
United States1 site
Tisch Cancer Institute, Mount Sinai Hospital
New York, New York, 10003
About this study
Official title: A Phase 1b/2 Trial of Dupilumab Given in Conjunction With PD-1 or PD-L1 Blockade and Anakinra in the Treatment of Relapsed/Refractory Metastatic NSCLC
This is a multi cohort, sequential enrollment clinical trial to determine the safety and tolerability of Dupilumab and Anakinra with PD-(L)1 blockade for patients with relapsed/refractory metastatic NSCLC. For Phase 2, to determine the effect of adding IL-4Ra and IL-1R blockade to PD-(L)1 blocking agents in patients with relapsed/refractory NSCLC, who have progressed on prior PD-(L)1 agents.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- Dupilumab, PD-1/PD-L1 blockade, Anakinra
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
three q3w cycles
PD-1/PD-L1 blockadeDrug
SOC immunotherapy with PD-1/PD-L1 blockade
AnakinraDrug
100 mg daily injection for Three q3w cycles
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab + anti-PD-1/PD-L1 (SOC) | Experimental | Patients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab will be administered Receives: Drug: Dupilumab; Drug: PD-1/PD-L1 blockade |
| Anakinra + Dupilumab + anti-PD-1/PD-L1 (SOC) | Experimental | Patients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab and anakinra will be administered Receives: Drug: Dupilumab; Drug: PD-1/PD-L1 blockade; Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLTs)
Phase 1: Dose Limiting Toxicity (DLTs) as defined based on the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
Measured: 9 weeks
Overall Response Rate (ORR)
Phase 2: Overall response rate by imaging at time of first repeat imaging (~9w from the start of therapy) using standard response criteria (RECIST v1.126). ORR is defined as the combined percent of the patients experiencing a partial response (PR) or a complete response (CR) at time of first reimaging.
Measured: 9 weeks
Secondary outcomes (4)
Best overall response (BORR)
Best overall response (BORR) will be a combined percent of the patients experiencing a partial response (PR) or a complete response (CR) at any point within the first year from the initiation of therapy, or until the documented progression of disease or start of a new anti-cancer therapy.
Measured: 5 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time in days from the first administration of dupilumab until documented progression of disease on imaging or death Defined as the time in days from the first administration of dupilumab until documented progression of disease on imaging or death
Measured: 5 years
Overall Survival (OS)
Overall survival (OS) is defined as the time in days from the first administration of dupilumab until documented death from any cause.
Measured: 5 years
Duration of response (DOR)
Duration of response (DOR) is defined as the time from which a patient achieves either a PR or a CR until subsequent progression of disease is documented radiographically or clinically.
Defined as the time from which a patient achieves either a PR or a CR until subsequent progression of disease is documented radiographically or clinically.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start10 Sep 2021
- Primary completion18 Sep 2025
- Study completion18 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Marron
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Marron, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Marron, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013450
- Sponsor's protocol ID
- STUDY-21-00907
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
LaMarche NM, Hegde S, Park MD, Maier BB, Troncoso L, Le Berichel J, Hamon P, Belabed M, Mattiuz R, Hennequin C, Chin T, Reid AM, Reyes-Torres I, Nemeth E, Zhang R, Olson OC, Doroshow DB, Rohs NC, Gomez JE, Veluswamy R, Hall N, Venturini N, Ginhoux F, Liu Z, Buckup M, Figueiredo I, Roudko V, Miyake K, Karasuyama H, Gonzalez-Kozlova E, Gnjatic S, Passegue E, Kim-Schulze S, Brown BD, Hirsch FR, Kim BS, Marron TU, Merad M. An IL-4 signalling axis in bone marrow drives pro-tumorigenic myelopoiesis. Nature. 2024 Jan;625(7993):166-174. doi: 10.1038/s41586-023-06797-9. Epub 2023 Dec 6.
PubMed 38057662
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Trial of Dupilumab Given in Conjunction With PD-1 or PD-L1 Blockade and Anakinra in the Treatment of Relapsed/Refractory Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT05013450
- Acronym / sponsor ID
- STUDY-21-00907
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Thomas MarronUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2030 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi cohort, sequential enrollment clinical trial to determine the safety and tolerability of Dupilumab and Anakinra with PD-(L)1 blockade for patients with relapsed/refractory metastatic NSCLC. For Phase 2, to determine the effect of adding IL-4Ra and IL-1R blockade to PD-(L)1 blocking agents in patients with relapsed/refractory NSCLC, who have progressed on prior PD-(L)1 agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab + anti-PD-1/PD-L1 (SOC) | Experimental | Drug: Dupilumab, Drug: PD-1/PD-L1 blockadePatients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab will be administered |
| Anakinra + Dupilumab + anti-PD-1/PD-L1 (SOC) | Experimental | Drug: Dupilumab, Drug: PD-1/PD-L1 blockade, Drug: AnakinraPatients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab and anakinra will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have a pathologically confirmed diagnosis of NSCLC
- Patients must have progressed (clinically or radiographically) on or following prior therapy with a PD-1 or PD-L1 targeted antibody
- Patients may have only 0 or 1 intervening lines of therapy from the prior PD-(L)1 blocking therapy
- Patient must be willing and able to provide blood samples (12 green-top tubes, roughly 100mL) at the time points indicated in the Study Calendar.
- Patient must be willing and able to have core needle biopsies, or forceps biopsies if clinically feasible by (Goal 3-6 biopsies, final number to be determined by the interventionalist performing the procedure as safe) of tumor prior to initiation of dupilumab and at the on-treatment time point. Should patients undergo pre-treatment or on-treatment biopsy procedure, and inadequate number of biopsies are obtained, they may proceed with initiation/continuation of treatment at the discretion of the investigator and treating physician
Key exclusion criteria (15 listed)
- Patients who have had chemotherapy within 14 days from start of therapy.
- Palliative radiotherapy is permitted at any time, if deemed in the best interest of the patient.
- 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), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumabthree q3w cycles | Drug | Anakinra + Dupilumab + anti-PD-1/PD-L1 (SOC), Dupilumab + anti-PD-1/PD-L1 (SOC) |
| PD-1/PD-L1 blockadeSOC immunotherapy with PD-1/PD-L1 blockade | Drug | Anakinra + Dupilumab + anti-PD-1/PD-L1 (SOC), Dupilumab + anti-PD-1/PD-L1 (SOC) |
| Anakinra100 mg daily injection for Three q3w cycles | Drug | Anakinra + Dupilumab + anti-PD-1/PD-L1 (SOC) |
Primary outcome
Dose Limiting Toxicity (DLTs)
Time frame: 9 weeks
Phase 1: Dose Limiting Toxicity (DLTs) as defined based on the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
Overall Response Rate (ORR)
Time frame: 9 weeks
Phase 2: Overall response rate by imaging at time of first repeat imaging (~9w from the start of therapy) using standard response criteria (RECIST v1.126). ORR is defined as the combined percent of the patients experiencing a partial response (PR) or a complete response (CR) at time of first reimaging.
4 secondary outcomes
Best overall response (BORR)
Time frame: 5 years
Progression-free survival (PFS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
Duration of response (DOR)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 38057662LaMarche NM, Hegde S, Park MD, Maier BB, Troncoso L, Le Berichel J, Hamon P, Belabed M, Mattiuz R, Hennequin C, Chin T, Reid AM, Reyes-Torres I, Nemeth E, Zhang R, Olson OC, Doroshow DB, Rohs NC, Gomez JE, Veluswamy R, Hall N, Venturini N, Ginhoux F, Liu Z, Buckup M, Figueiredo I, Roudko V, Miyake K, Karasuyama H, Gonzalez-Kozlova E, Gnjatic S, Passegue E, Kim-Schulze S, Brown BD, Hirsch FR, Kim BS, Marron TU, Merad M. An IL-4 signalling axis in bone marrow drives pro-tumorigenic myelopoiesis. Nature. 2024 Jan;625(7993):166-174. doi: 10.1038/s41586-023-06797-9. Epub 2023 Dec 6.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Marron, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dupilumab, PD-1/PD-L1 blockade and Anakinra in people with Metastatic Non-small Cell Lung Cancer, run by Thomas Marron at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLTs) (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05013450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.