NCT06822543

A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Latin American Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.

Detailed description

This is a phase II, single-arm, multicenter trial. Patients with metastatic NSCLCs with brain metastases and without known actionable mutations will be enrolled. Patients who are eligible for the study will receive Datopotamab-deruxtecan 6 mg/kg, Carboplatin AUC 6, and Pembrolizumab 200 mg flat dose every three weeks, for four cycles, followed by maintenance of Datopotamab-deruxtecan 6 mg/kg and Pembrolizumab 200 mg until unacceptable toxicity or disease progression. Patients who present intracranial progression but do not present concurrent systemic progression may undergo stereotactic radiosurgery and continue systemic therapy on study as per investigator's decision. Patients will undergo medical evaluation and laboratory tests (hematology and blood chemistry) every 3 weeks. Abdomen/pelvis and chest CT scans, as well as brain MRIs, will be obtained at baseline, every 6 weeks during the first 24 weeks, then every 9 weeks (±7 days). Patient reported outcomes will be assessed using EORTC QLQ-C30 and QLQ-LC13 questionnaires at baseline and during treatment.

Conditions

• Lung Cancer
• Non Small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
DRUG	Datopotamab deruxtecan	Datopotamab deruxtecan (Dato-DXd) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload and a cleavable linker.
DRUG	Carboplatin	Carboplatin is a platinum compound chemotherapy used to treat lung cancer with a known safety profile. For more details on specific indications refer to the approved product label.

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-06-30
• Completion: 2028-11-01
• First posted: 2025-02-12
• Last updated: 2025-09-29

Locations

1 site across 1 country: Brazil