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OncoMatch/Clinical Trials/NCT06838273

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Is NCT06838273 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BL-B01D1 and Osimertinib for non-small cell lung cancer.

Phase 3RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06838273Data as of May 2026

Treatment: BL-B01D1 · Osimertinib · OsimertinibThis trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated 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 sensitive mutation

Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples

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

Patients with previous systemic therapy

Cannot have received: EGFR tyrosine kinase inhibitor

Patients had received EGFR-TKI therapy

Cannot have received: autologous or allogeneic stem cell transplantation

Had autologous or allogeneic stem cell transplantation history

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

No severe cardiac dysfunction, left ventricular ejection fraction ≥50%

No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period; Urinary protein ≤2+ or < 1000mg/24h

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

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