An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Real-World Progression-Free Survival (rwPFS)
研究概览
简要总结
This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.
详细描述
Background & Unmet Need:
Lorlatinib, a third-generation ALK tyrosine kinase inhibitor (TKI), is a standard treatment option for patients with advanced ALK-positive lung adenocarcinoma, particularly following the failure of earlier-generation ALK inhibitors. Despite its potent central nervous system penetration and broad coverage of ALK resistance mutations, acquired resistance and disease progression remain inevitable for most patients. Currently, there is no established standard of care for patients who progress on lorlatinib, representing a significant unmet clinical need.
Rationale for Iruplinalkib:
Iruplinalkib is a novel ALK inhibitor exhibiting high selectivity and activity against a broad spectrum of ALK resistance mutations, including those associated with resistance to prior ALK TKIs. While preliminary clinical studies have demonstrated promising antitumor activity and a manageable safety profile in patients with ALK-positive non-small cell lung cancer (NSCLC), data specifically evaluating iruplinalkib in the post-lorlatinib setting are limited, particularly within real-world clinical practice.
Study Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population: Male or female patients aged ≥18 years.
- •Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.
- •Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).
- •Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.
- •Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.
- •Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.
- •Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).
排除标准
- •Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., < 1 week/cycle) before withdrawal for non-medical reasons.
- •Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).
- •Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.
- •Pregnancy: Pregnant or breastfeeding women.
- •Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).
研究组 & 干预措施
Treatment group
干预措施: Iruplinalkib tablets (Drug)
结局指标
主要结局
Real-World Progression-Free Survival (rwPFS)
时间窗: From index date through study completion, an average of 36 months
Time from treatment initiation to the earliest of death or clinical disease progression. Progression is defined by the treating provider's assessment recorded in the medical record, based on radiology, laboratory, or physical exam findings, distinct from RECIST-based radiographic progression.
次要结局
- Time to Next Treatment (TTNT)(From index date to the start of next line of therapy, assessed up to 36 months)
- Overall survival (OS)(From index date through study completion, an average of 36 months)
- Treatment-related adverse reactions ( TRAE )(From the index date through the date of Iruplinalkib discontinuation or the start of a new anti-cancer therapy (whichever occurs first), assessed up to 36 months.)
研究者
Fen Wang
Associate chief physician
Peking University Shenzhen Hospital