Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial

Официальное название

Furmonertinib Combined With Local Therapy in Inoperable or Surgery-Refusing Early-Stage Non-Small Cell Lung Cancer:A Single-arm, Phase II Study

Обзор

The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery. The main purposes of this study is to answer: Can ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?

Вмешательства

• Препарат furmonertinib
  furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years
• Процедура ablation
  1. Immobilization and image guidance: Supine or prone position; vacuum cushion or mask to limit motion. CT guidance for entry point, angle, and depth; ultrasound for selected peripheral lesions. 2. Ablation target planning: Ablation zone should cover GTV with ≥5-10 mm margin. For tumors near critical structures, pursue adequate margin when safe; consider heat sink or thermal isolation. 3. Ablation procedure: Choose MWA, RFA, or cryoablation based on tumor size, location, anatomy, and resources.
• Лучевая терапия stereotactic body radiotherapy
  1. Immobilization: Use a thermoplastic mask or vacuum cushion for immobilization based on the treatment site. 2. CT simulation: After immobilization and stabilization of breathing, laser alignment is performed, followed by 4D-CT simulation (preferred) or conventional CT simulation. 3. Radiotherapy target delineation and dose: GTV includes the primary lung tumor and metastatic lymph nodes after chemotherapy. A 5-mm margin is added to form the PTV. 4. Radiotherapy plan: For peripheral lesions: 48

Первичные конечные точки

• 2-year EFS rate [Срок оценки: Within two years after the treatment]

Вторичные конечные точки (4)

• 3-year EFS rate [Срок оценки: Within three years after the treatment]
• overall survival [Срок оценки: through study completion, an average of 5 year]
• Local control rate (LCR) [Срок оценки: through study completion, an average of 1 year]
• Time to distant metastasis [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Voluntarily participate in the clinical study
• Aged ≥ 18 years at the time of signing the informed consent form
• Histologically or cytologically confirmed early-stage T1-3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence
• Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations
• ECOG performance status score of 0-2
• Deemed medically inoperable or refuse surgery after multidisciplinary evaluation
• Pulmonary lesions suitable for ablation or radiotherapy (either modality)
• Adequate major organ function

Критерии исключения

• Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug
• Known contraindications to ablation or radiotherapy
• Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan
• Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose
• Patients with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV-RNA indicating viral replication)
• Receipt of curative-intent radiotherapy within 3 months prior to the first dose
• Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered)
• Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

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

• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07517640 · 2026LY0109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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