NCT07642024招募中2 期
A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 3
研究概览
简要总结
This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign informed consent and agree to comply with the protocol requirements;
- •Aged ≥18 years and ≤75 years, regardless of gender;
- •Expected survival time ≥3 months;
- •Patients with non-small cell lung cancer;
- •One of the EGFR sensitive mutation types detected in the tumor tissue;
- •Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;
- •Undergo pulmonary function testing within 28 days prior to the first dose;
- •ECOG performance status score of 0 or 1;
- •No severe cardiac dysfunction;
- •Organ function levels must meet the required criteria;
- •Urine protein ≤1+ or <1000 mg/24h;
- •For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.
排除标准
- •SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
- •Trial participants who subsequently receive only segmentectomy or wedge resection;
- •Trial participants deemed surgically inoperable by the study center's surgical evaluation;
- •Undergoing major surgery within 4 weeks prior to the first dose, among others;
- •Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others;
- •Receiving long-term systemic corticosteroid therapy with prednisone >10 mg/day within 2 weeks prior to randomization, among others;
- •History of severe heart disease or cerebrovascular disease;
- •Prolonged QTc interval, complete left bundle branch block, etc.;
- •Any thrombotic event within 6 months prior to screening;
- •Trial participants with known or suspected interstitial lung disease, among others;
- •Diagnosis of active malignant tumors within 5 years prior to study randomization;
- •Hypertension inadequately controlled by two antihypertensive medications;
- •Trial participants with poorly controlled blood glucose;
- •Severe infection occurring within 4 weeks prior to study randomization, among others;
- •Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;
- •Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
- •Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
- •Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
- •Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.;
- •History of allergy to the investigational drug, etc.;
- •History of solid organ transplantation, 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;
- •Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;
- •Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.
研究者
研究点 (3)
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