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Recruiting
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)
Conditions: Lung Cancer, Non Small Cell Lung Cancer, Brain Metastases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 46
Sponsor: Latin American Cooperative Oncology Group
Location: CRIO - Centro Regional Integrado de Oncologia Fortaleza Ceará
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.
Eligibility Criteria
Inclusion Criteria:
\- Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of NSCLC will be enrolled in this study.
Histologically confirmed metastatic non-squamous NSCLC with PD-L1 tumor proportion score \470 msec regardless of sex; Myocardial infarction within 6 months prior to inclusion; Uncontrolled angina pectoris within 6 months prior to inclusion; Known LVEF \
Source: ClinicalTrials.gov (NCT06822543). StuddyBuddy aggregates publicly available trial information.