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

Sponsor
Latin American Cooperative Oncology Group
Study ID
NCT06822543
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    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).
  • Datopotamab deruxtecan — DRUG
    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.
  • Carboplatin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 12, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm: pembrolizumab, datopotamab-deruxtecan, and carboplatin
    Study treatment: * INDUCTION: Pembrolizumab 200 mg IV Q3W; Datopotamab-Deruxtecan 6mg/kg IV Q3W; Carboplatin AUC 5 IV Q3W. * For four (4) cycles. * MAINTENANCE: Pembrolizumab 200 mg IV Q3W for 35 cycles; Datopotamab-Deruxtecan 6mg/ kg IV Q3W.\* * until disease progression or unacceptable toxicity.

Primary Outcome Measure

Confirmed Intracranial Objective Response Rate (iORR) as Measured by the RANO-BM Criteria [ Time Frame: Through study primary completion, an average of 2 years ]

Central Contacts

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