Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors

Официальное название

Protocol for a Prospective, Single-arm, Multicenter Clinical Study on the Efficacy and Safety of Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors

Обзор

The primary objective is to evaluate the efficacy and safety of Iruplinalkib Tablets as postoperative adjuvant therapy in patients with stage IA, ALK-positive NSCLC with high-risk factors.

Подробное описание

This Prospective, Single-arm, Multicenter Clinical Study aims to evaluate the Efficacy and Safety of Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC with High-risk Factors.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Вмешательства

• Препарат Iruplinalkib tablets
  Iruplinalkib: Refer to the drug insert. The tablets should be swallowed whole and must not be crushed, divided, or chewed. The recommended dosage is once daily, which can be taken on an empty stomach or with food. From Day 1 to Day 7, the dose is 60mg per administration. If tolerated, the dose should be increased to 180mg per administration starting from Day 8, and continued until disease progression, intolerable toxicity, or completion of the 2-year treatment period.If a subject misses a schedu

Первичные конечные точки

• 3-year DFS rate [Срок оценки: Up to 36 months]

Вторичные конечные точки (1)

• Overall Survival (OS) [Срок оценки: Time Frame: up to 36 month]

Критерии участия

Критерии включения

\- 1.Age ≥18 years, male or female. 2.ECOG Performance Status (PS) score: 0-1. 3.Expected survival ≥12 weeks. 4.Histologically or cytologically confirmed non-small cell lung cancer. 5.ALK-positive status confirmed by the investigator (NGS). 6.Clinical stage IA (maximum tumor diameter ≤3 cm, AJCC 9th edition). 7.No prior treatment with any ALK TKI targeted therapy. 8.The patient has undergone curative-intent tumor resection (sublobar resection, lobectomy, sleeve resection).

9.Organ function meets the following requirements (use of any blood products or hematopoietic growth factors within 14 days prior to enrollment is not allowed):

• Hemoglobin ≥90 g/L;
• White blood cell count ≥3.5 × 10⁹/L;
• Absolute neutrophil count ≥1.5 × 10⁹/L;
• Platelets ≥80 × 10⁹/L;
• AST, ALT ≤2.5 × ULN; if liver metastases are present, AST, ALT ≤5 × ULN;
• Total bilirubin (TBIL) ≤1.5 × ULN;
• Urea/BUN and creatinine (Cr) ≤1.5 × ULN (and creatinine clearance (CCr) ≥50 mL/min);
• Left ventricular ejection fraction (LVEF) ≥50%. 10.Patients of childbearing potential/fertile males must agree to use effective contraception.

Критерии исключения

• 1.Presence of pathological components other than non-small cell carcinoma in tissue or cytology.

2\. History of allergy to ALK TKI agents or their ingredients. 3. Poorly controlled underlying diseases before enrollment, such as coronary artery disease, heart failure, cerebral infarction, hypertension, chronic obstructive pulmonary disease, interstitial lung disease, rheumatic diseases, peptic ulcer, etc. (to be determined by the investigator's assessment).

4\. Active pulmonary tuberculosis (TB), active tuberculosis infection, or active syphilis infection; eligibility for the clinical trial may be reassessed after the condition is stably controlled.

5\. Positive anti-HIV test; positive hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal; active hepatitis C virus (HCV) infection.

6\. Serious infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C).

7\. Psychiatric disorders or social conditions that limit the subject's compliance with study requirements or affect their ability to provide written informed consent.

8\. Any arterial thromboembolic event within 6 months prior to the first dose, venous thromboembolic events of Grade 3 or above, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 3 months prior to the first dose.

9\. History of severe bleeding tendency or coagulation dysfunction; obvious active bleeding within 1 month prior to the first dose (to be determined by the investigator's assessment).

10\. History of drug abuse, alcohol abuse, or substance abuse. 11. Pregnant or lactating women. 12. Patients deemed unsuitable for participation in this study by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07330076 · E20251139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗