NCT05807048

Daratumumab in STK11 Mutated NSCLC

A Single-Arm Phase 2 Study of Daratumumab Subcutaneous (SC) in Previously Treated STK11/LKB1 Mutated Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm study of daratumumab in metastatic non-small cell lung cancer (NSCLC) patients with an STK11/LKB1 mutation. Patients will have received previous standard of care treatment including chemotherapy, immunotherapy and targeted therapy. Patients will be treated with the standard subcutaneous dosing of daratumumab (weekly for 8 administrations, then every 2 weeks for 8 administrations then every 4 weeks until progression). All follow-up visits and imaging will be performed as per standard of care. This is a signal finding study and an overall response rate ≥20% is considered clinically meaningful.

Conditions

• Non-small Cell Lung Cancer With STK11/LKB1 Mutation

Interventions

Type	Name	Description
DRUG	Daratumumab and Hyaluronidase-fihj	DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection for subcutaneous use. Supplied as individually packaged single-dose vials providing 1,800 mg of daratumumab and 30,000 units of hyaluronidase per 15 mL.
DRUG	Pre-Intervention Medication	The following pre-medications will be administered 1-3 hours before each dose of DARZALEX FASPRO: * Acetaminophen 650 to 1,000 mg orally * Diphenhydramine 25 to 50 mg (or equivalent) orally or intravenously * Montelukast 10mg PO prior to DARZALEX FASPRO®. * Methylprednisolone 100 mg (or equivalent) orally or intravenously
DRUG	Post-Intervention Medication	The following post-medications will be administered: * Methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long acting corticosteroid) orally for 2 days starting the day after the administration of DARZALEX FASPRO®. * Patients with a history of chronic obstructive pulmonary disease will be prescribed short and long-acting bronchodilators and inhaled corticosteroids. * Antiviral prophylaxis for herpes zoster reactivation must be initiated within one week of daratumumab hyaluronidase-fihj administration and continued for 3 months following the end of treatment.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-11-11
• Completion: 2025-11-11
• First posted: 2023-04-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study