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.
Treatment: BL-B01D1 · Docetaxel — This 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.
Check if I qualifyExtracted 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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