Daratumumab in STK11 Mutated NSCLC

PHASE2RecruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
Non-small Cell Lung Cancer With STK11/LKB1 Mutation
Interventions
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."

Trial Locations (1)

10016

RECRUITING

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER