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

First listed

Apr 10, 2023

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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