Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)

Официальное название

Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study

Обзор

In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.

Вмешательства

• Препарат Furmonertinib+cisplating/pemetrexed
  Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles

Первичные конечные точки

• Objective response rate [Срок оценки: 7 days before surgery]

Вторичные конечные точки (7)

• Major pathological response rate [Срок оценки: 7 days after surgery]
• Pathological complete response rate [Срок оценки: 7 days after surgery]
• R0 resection rate [Срок оценки: 7 days after surgery]
• the TNM downstaging rate [Срок оценки: 7 days before surgery]
• Event-free survival [Срок оценки: 2 years]
• Overall survival [Срок оценки: Approximately 5 years following the first dose of study drugs]
• drug safety and surgical complications [Срок оценки: Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.]

Критерии участия

Критерии включения

• With written informed consent before any study procedure
• Histology or cytology diagnose of non-small cell lung cancer within 60 days
• Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology
• EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
• Without prior anti-tumor treatment
• With at least one measurable lesions
• ECOG performance status 0-1
• Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age

Критерии исключения

• EGFR Exon 20 insertions positive
• Mixed with small cell cancer, or other mixed types of lung cancer
• Any prior anti-tumor treatment
• Major surgery within 4 weeks before enrollment
• Women with pregnancy or breastfeeding
• Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment
• With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
• With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
• Severe gastrointestinal diseases which may affect the intake and absorption of study drug
• Prolongation of ECG QTc or with relative risk factors
• History of interstitial lung disease or with relative risk factors
• Inadequate organ function of hematology, liver and kidney
• Allergic to study drugs or any component
• Poor adherence or other situation judged by investigator
• Patients who had participated other clinical studies of tumors

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

• Tangdu Hospital — Сиань

Идентификаторы

NCT: NCT05430802 · PMR-21011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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