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OncoMatch/Clinical Trials/NCT06951464

A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC

Is NCT06951464 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and Almonertinib for non-small cell lung cancer.

Phase 2RecruitingSichuan UniversityNCT06951464Data as of May 2026

Treatment: BL-B01D1 · AlmonertinibThis is a Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable 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

Disease stage

Required: Stage II, IIIA, IIIB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic or local anti-tumor therapy

Patients who have received previous systemic or local anti-tumor therapy for non-small-cell lung cancer

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L

Kidney function

Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula)

Liver function

Total bilirubin (TBIL) ≤1.5×ULN, AST and ALT ≤2.5×ULN

Cardiac function

No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%

Organ function levels must meet the following criteria: Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN, AST and ALT ≤2.5×ULN; Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula); Albumin ≥30 g/L. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%.

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

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