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Daratumumab in STK11 Mutated NSCLC

NCT05807048 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Salman Punekar · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-11-11
Completion
2025-11-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05807048 on ClinicalTrials.gov