OncoMatch/Clinical Trials/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)
Is NCT06822543 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Datopotamab deruxtecan for lung cancer.
Treatment: Pembrolizumab · Datopotamab deruxtecan · Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Biomarker criteria
Required: ALK wild-type
Required: PD-L1 (CD274) tumor proportion score <50% (<50%)
Required: EGFR wild-type
Required: HER2 (ERBB2) wild-type
Required: MET wild-type
Required: NTRK1 wild-type
Required: NTRK2 wild-type
Required: NTRK3 wild-type
Required: RET wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage IV
Metastatic disease required
Presence of 1 or more measurable central nervous system (CNS) metastases... Presence of 1 or more measurable extracranial lesion
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: Patients who received chemotherapy or immunotherapy for localized or locally advanced NSCLC are eligible if progression occurred at least 6 months after the last dose of systemic treatment.
No prior systemic therapy for advanced or metastatic NSCLC. Patients who received chemotherapy or immunotherapy for localized or locally advanced NSCLC are eligible if progression occurred at least 6 months after the last dose of systemic treatment.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the last 2 weeks
Kidney function
Creatinine OR measured/calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Cardiac function
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex; Known LVEF <50% by ECHO or MUGA scan within 28 days before inclusion; New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening; Uncontrolled hypertension within 7 days before inclusion
Have adequate organ function... Hematological: ANC ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; Renal: Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN; Hepatic: Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases); Cardiac: Mean QTcF >470 msec, LVEF <50%, NYHA Class 2-4 CHF, uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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