Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC

Официальное название

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC: a Single-center, Randomized Controlled Trial

Обзор

The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.

Вмешательства

• Препарат Fumetinib combined platinum-based double chemotherapy
  Fumetinib combined platinum-based double chemotherapy
• Комбинированный продукт Concurrent Radiochemotherapy
  Concurrent Radiochemotherapy

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: up to 60 months]

Вторичные конечные точки (1)

• Major pathologic response (MPR) [Срок оценки: up to 4 months]

Критерии участия

Критерии включения

• NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
• At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
• No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
• With the feasibility to receive radical surgery ;
• Good lung function that could tolerate surgical treatment;
• Minimum age: 18 years;
• At least one measurable tumor foci (the longest diameter measured by CT shall be > 10 mm);
• Other major organs shall function well (liver, kidney, blood system, etc.):
• ECOG PS score shall be 0-1;
• The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
• The patient shall sign the Informed Consent Form.

Критерии исключения

• The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
• The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
• The patient is a carrier of HIV;
• The patient has had or is currently suffering from interstitial lung disease;
• The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
• The patient is allergic to befotertinib or its any excipients;
• The patient is allergic to bevacizumab or its any excipients;
• The patient is allergic to platinum-based double chemotherapy or its any excipients;
• The female patient is in pregnancy or lactation period;
• There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

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 · 1 центр

• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07742332 · LungMate-030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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