BL-B01D1 plus osimertinib versus osimertinib alone for EGFR-mutated lung cancer after chemoradiation

Trial details

Who runs it

Sichuan Baili Pharmaceutical Co., Ltd.

Trial code

NCT07640789

Record updated

10 September 2026

Original description

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.Read full original descriptionShow less

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.

Inclusion: Voluntarily sign the informed consent form and comply with the protocol requirements; Age ≥ 18 years and ≤ 75 years, regardless of gender; Expected survival time ≥ 3 months; Unresectable Stage III non-small cell lung cancer; Detection of one of the EGFR-sensitive mutation types in tumor tissue; Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year; In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent; In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization; Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0; ECOG performance status score of 0 or 1; No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; Organ function levels must meet the requirements; Urine protein ≤ 1+ or < 1000 mg/24h; For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends.

Exclusion: The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy; Major surgery within 4 weeks prior to the first dose; Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening; Diagnosis of active malignancy within 5 years prior to study randomization; Concurrent lung disease resulting in clinically severe respiratory impairment; Severe infection within 4 weeks prior to study randomization; Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent; Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent; History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug; Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization; History of severe heart disease or cerebrovascular disease; Hypertension poorly controlled by two antihypertensive medications; Current radiation pneumonitis of Grade ≥2 as defined by CTCAE; Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis; History of autologous or allogeneic stem cell transplantation; Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection; History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction; Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons; Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3; Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; Trial participants with poorly controlled blood glucose levels; SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types; Large serous cavity effusions or symptomatic serous cavity effusions; Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx.

ClinicalTrials.gov NCT07640789