Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC

Официальное название

A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer

Обзор

This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

Подробное описание

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).

Вмешательства

• Препарат Afatinib plus chemotherapy as conversion treatment
  Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.

Первичные конечные точки

• The rate of NSCLC converting to resectable tumors [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (9)

• R0 resection rate [Срок оценки: immediately after the surgery]
• Major pathologic response (MPR) Rate [Срок оценки: Up to 12 weeks]
• Pathologic complete response (pCR) Rate [Срок оценки: Up to 12 weeks]
• Tumor downstaging rate [Срок оценки: Up to 12 weeks]
• Objective response rate (ORR) [Срок оценки: Up to five years]
• Disease control rate (DCR) [Срок оценки: Up to five years]
• Event-free survival (EFS) [Срок оценки: Up to five years]
• The 2-year progression-free survival (PFS) rate [Срок оценки: Up to two years]
• Overall Survival (OS) [Срок оценки: Up to five years]

Критерии участия

Критерии включения

• Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
• Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
• ECOG Performance Status of 0-1
• At least one measurable lesion according to RECIST 1.1
• Adequate organ and marrow function

Критерии исключения

• Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
• The presence of malignant pleural effusion
• Prior systemic anti-cancer therapy for non-small cell lung cancer
• Prior local radiotherapy for NSCLC
• Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment

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

• Shandong Public Health Clinical Center — Цзинань

Идентификаторы

NCT: NCT06709859 · GWLCZXEC2024-56-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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