Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088771
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-06
Brief Title:
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Phase 12 Study of Combined Treatment With Dupilumab Anti-IL-4Ra and Cemiplimab Anti-PD-1 in Patients With Early-stage Resectable NSCLC
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 12 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 On Day 1 participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab 2 SC injections of 300 mg and 350 mg of IV cemiplimab Participants will undergo standard of care surgery which will be scheduled within 7 days of Day 15 Participants will be followed up 30 days following administration of dupilumab and cemiplimab for adverse event AE and dose limiting toxicity DLT monitoring Participants will be offered adjuvant therapy as per standard of care outside the context of this clinical treatment and undergo subsequent standard of care monitoring for recurrence The study team will monitor the status of the participant through chart review or by telephone should the patient not continue to follow with a physician at Mount Sinai for up to 5 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCO 23-0743 | OTHER_GRANT | Cancer Research Institute Clinical Innovator Grant Award | None |