A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metas… (NCT06382129) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02)
China698 participantsStarted 2024-05-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Voluntarily sign the informed consent and follow the requirements of the protocol;
✓. Age ≥18 years old;
✓. Expected survival time ≥3 months;
✓. Patients with histologically or cytologically confirmed locally advanced or metastatic EGFR wild-type non-small cell lung cancer;
✓. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
✓. Must have at least one measurable lesion according to RECIST v1.1 definition;
✓. ECOG 0 or 1;
✓. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
Exclusion criteria
✕. Previous histological or cytological evidence of small cell or mixed small/non-small cell components;
✕. Patients with EGFR L858R mutation, EGFR 19DEL mutation or EGFR T790M positive;
✕. Chemotherapy, targeted therapy, biological therapy, etc., and palliative radiotherapy or antineoplastic therapy within 2 weeks before randomization;
✕. Previous ADCs with TOPI inhibitors as toxins, antibodies/ADCs targeting EGFR and/or HER3;