Daratumumab in STK11 Mutated NSCLC

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Daratumumab and Hyaluronidase-fihj — DRUG
  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.
• Pre-Intervention Medication — DRUG
  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
• Post-Intervention Medication — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 1, 2023

Status verified

Mar 2026

Primary completion

Nov 11, 2025

Completion

Nov 11, 2025

Study Design

Enrollment

8 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Patients with STK11/LKB1-Mutated NSCLC
  Participants will receive daratumumab 1800mg and hyaluronidase 30,000 units (combined product DARZALEX Faspro) administered subcutaneously per the following dosing schedule: * Once per week for 8 administrations (Week 1-8) * Once every two weeks for 8 administrations (Week 9-16) * Once every 4 weeks until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR) based on RECIST 1.1 Criteria [ Time Frame: Up to Month 24 ]

Locations (1)

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