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OncoMatch/Clinical Trials/NCT06382129

A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer

Is NCT06382129 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BL-B01D1 and Docetaxel for non-small cell lung cancer.

Phase 3RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06382129Data as of May 2026

Treatment: BL-B01D1 · DocetaxelThis trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR wild-type

Excluded: EGFR exon 19 deletion

Excluded: EGFR l858r

Excluded: EGFR t790m

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: chemotherapy

Exception: within 2 weeks before randomization

Chemotherapy ... within 2 weeks before randomization

Cannot have received: targeted therapy

Exception: within 2 weeks before randomization

targeted therapy ... within 2 weeks before randomization

Cannot have received: biological therapy

Exception: within 2 weeks before randomization

biological therapy ... within 2 weeks before randomization

Cannot have received: palliative radiotherapy

Exception: within 2 weeks before randomization

palliative radiotherapy ... within 2 weeks before randomization

Cannot have received: antineoplastic therapy

Exception: within 2 weeks before randomization

antineoplastic therapy within 2 weeks before randomization

Cannot have received: antibody-drug conjugate

Previous ADCs with TOPI inhibitors as toxins

Cannot have received: antibody-drug conjugate

antibodies/ADCs targeting EGFR and/or HER3

Cannot have received: stem cell transplant

A history of autologous or allogeneic stem cell transplantation

Lab requirements

Blood counts

Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; blood transfusion is not allowed within 14 days before the screening period, and no cell growth factor drugs are allowed; urine protein ≤2+ or < 1000mg/24h

Kidney function

Liver function

Cardiac function

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

The organ function level must meet the requirements ... blood transfusion is not allowed within 14 days before the screening period, and no cell growth factor drugs are allowed; 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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