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OncoMatch/Clinical Trials/NCT06498986

A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Is NCT06498986 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and Osimertinib Mesylate Tablets for non-small cell lung cancer.

Phase 2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06498986Data as of May 2026

Treatment: BL-B01D1 · Osimertinib Mesylate TabletsThis phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR sensitizing mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Cannot have received: egfr tyrosine kinase inhibitor

Lab requirements

Blood counts

Blood transfusion not allowed within 14 days before screening; no cell growth factor drugs allowed; blood coagulation function: international standardization ratio of 1.5 or less, and the part activated clotting time live enzymes acuities were 1.5 x ULN; urine protein ≤2+ or ≤1000mg/24h

Kidney function

Liver function

Cardiac function

No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia [excluded]

The level of organ function must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed; Blood coagulation function: international standardization ratio of 1.5 or less, and the part activated clotting time live enzymes acuities were 1.5 x ULN; Urine protein ≤2+ or ≤1000mg/24h; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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