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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 (Jun 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and Almonertinib for non-small cell lung cancer.

Phase 2RecruitingSichuan UniversityNCT06951464Data as of Jun 2026Location: China

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

Treatments studied

Targeted therapy

Almonertinib

Other

BL-B01D1

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06951464 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require EGFR?

Yes, EGFR sensitizing mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or IIIA or IIIB is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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