drugset
drugset / Trial / NCT05807048

Daratumumab in STK11 Mutated NSCLC

NCT05807048 ↗

Phase 2 Completed 8 enrolled NYU Langone Health
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-06-01
Primary completion
2025-11-11
Completion
2025-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab and Hyaluronidase-fihj Unknown 1800 mg Subcutaneous
Subject Daratumumab and Hyaluronidase-fihj Unknown 30000 iu Subcutaneous
Background Acetaminophen Small molecule 650 mg Oral
Background Acetaminophen Small molecule 1000 mg Oral
Background Diphenhydramine Unknown 25 mg Oral
Background Diphenhydramine Unknown 50 mg Oral
Background Methylprednisolone Other / unclassified 20 mg Oral
Background Methylprednisolone Other / unclassified 100 mg Oral
Background Montelukast Other / unclassified 10 mg Oral

Indications

lung cancer