A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Osimertinib
  Oral administration for a cycle of 3 weeks.
• Препарат Carboplatin
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Pemetrexed
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Cisplatin
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Major Pathological Response (MPR) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (5)

• Pathologic complete response (pCR) [Срок оценки: Up to approximately 24 months]
• Event-Free Survival (EFS) [Срок оценки: Up to approximately 24 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shanghai East Hospital — Шанхай
• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07642024 · BL-B01D1-319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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