Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

Официальное название

Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study

Обзор

Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.

Вмешательства

• Препарат Icotinib
  125mg 1tt(Take 1 tablet 3 times a day) orally.
• Препарат Cisplatin
  75 mg/m2 (IV，Q3W)
• Препарат Carboplatin
  AUC 5 (IV, Q3W)
• Препарат Pemetrexed
  500 mg/m2 (IV, Q3W)

Первичные конечные точки

• Major pathological response(MPR) [Срок оценки: Up to approximately 30 months]

Вторичные конечные точки (5)

• Pathological complete response (pCR) [Срок оценки: Up to approximately 30 months]
• Objective response rate(ORR) [Срок оценки: Up to approximately 30 months]
• R0 resection rate [Срок оценки: Up to approximately 30 months]
• Disease-free survival(DFS) [Срок оценки: Up to approximately 72 months]
• Overall survival(OS) [Срок оценки: Up to approximately 72 months]

Критерии участия

Критерии включения

• Written informed consent
• Male or female, aged ≥18 years and ≤75 years
• Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology)
• Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation
• A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone
• ECOG PS 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
• Adequate organ and marrow function as defined by:

• Hemoglobin: ≥9.0 g/dL
• Absolute neutrophil count: ≥1.5 × 109/l
• Platelet count: ≥100 × 109/l
• Serum bilirubin: ≤1.5 ULN
• ALT and AST: ≤2.5 × ULN
• Creatinine clearance: ≥60 ml/min
• Life expectancy of 6 months prior to randomization

Критерии исключения

• Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy
• EGFR-TKI-sensitizing mutations with T790M
• Mixed small cell and non-small-cell lung cancer histology
• T4 tumors infiltrating the aorta, esophagus and/or heart
• Bulky N2 disease
• Candidates for segmentectomies or wedge resections only
• Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD
• Severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy

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

Китай · 1 центр

• Liaoning Cancer Hospital & Institute — Шэньян

Публикации

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Идентификаторы

NCT: NCT05132985 · NIC-0102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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