Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations

Официальное название

A Prospective, Single-arm Study of Adebrelimab in Combination With Paclitaxel for Injection (Albumin Bound) and Platinum Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) Harboring Driver Gene Mutations

Обзор

This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations

Вмешательства

• Препарат Adebrelimab
  Adebrelimab IV
• Препарат paclitaxel for injection (albumin bound)
  paclitaxel for injection (albumin bound) IV
• Препарат Cisplatin or Carboplatin
  Cisplatin or Carboplatin IV

Первичные конечные точки

• Pathological complete response rate [Срок оценки: at 12 months]

Вторичные конечные точки (6)

• Major pathologic response rate [Срок оценки: 12 months]
• R0 rate [Срок оценки: 12 months]
• Event Free Survival [Срок оценки: up to 5 years]
• Overall Survival [Срок оценки: up to 5 years]
• Objective response rate [Срок оценки: 12 months]
• Adverse Events [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• Male or female aged ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Resectable non-small cell lung cancer harboring driver gene mutations.
• At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1.
• Have adequate organ function.
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception.
• Voluntarily comply with the treatment protocol.

Критерии исключения

• Previously treated with any anti-tumor therapy;
• Subject with known autoimmune disease
• Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C.
• Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites).
• Subject with severe liver and kidney dysfunction.
• Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study
• Subject with previous malignancies within 5 years, except for cured in situ cancer.
• Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function.
• Subject with uncontrolled hypertension.
• Prior organ transplantation including allogenic stem-cell transplantation.
• Known hypersensitivity to the study drug or any of its excipients.
• Other situations that the investigator considers unsuitable for the enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06299371 · MA-NSCLC-II-033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗