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治験 NCT07374614 (SAILOR)（対象：非小細胞肺癌、ALK、Iruplinalkib、Lorlatinib、実世界研究、観察研究）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib (SAILOR) 20 RWE 観察研究

募集中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07374614 (SAILOR) は 観察研究 臨床試験 で、非小細胞肺癌、ALK、Iruplinalkib、Lorlatinib、実世界研究、観察研究 に関するものです。現在は 募集中 で、2026年1月31日 から開始しています。20 名の参加者 の募集が計画されています。この試験は Peking University Shenzhen Hospital によって主導され、2028年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月29日 です。
概要
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.
詳細説明
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 inevita...

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公式タイトル

An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment

疾患名
非小細胞肺癌ALKIruplinalkibLorlatinib実世界研究観察研究
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • SAILOR
  • 2025-324
NCT番号
NCT07374614
開始日
2026-01-31
最終更新日
2026-01-29
終了予定日
2028-12-31
目標参加者数
20
試験の種類
観察研究
状況
募集中
キーワード
Iruplinalkib
ALK-postive
Post-Lorlatinib
Advanced Lung Adenocarcinoma
群（アーム）／介入
参加グループ/群介入/治療法
Treatment group
Iruplinalkib tablets
180mg, QD
主要評価項目
評価指標指標の説明時間枠
Real-World Progression-Free Survival (rwPFS)
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.
From index date through study completion, an average of 36 months
副次評価項目
評価指標指標の説明時間枠
Time to Next Treatment (TTNT)
TTNT is defined as the time interval from the index date (date of first dose of the study treatment) to the date of the first administration of a new (subsequent) systemic anti-cancer therapy. This outcome distinguishes the duration of the current line of therapy before a switch is made. Patients who die without receiving a subsequent therapy are censored at the date of death. Patients who remain on the study treatment or discontinue treatment without starting a new line are censored at their last known activity date or the data cutoff date.
From index date to the start of next line of therapy, assessed up to 36 months
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause
From index date through study completion, an average of 36 months
Treatment-related adverse reactions ( TRAE )
All AEs will be evaluated by the investigators to determine their potential relationship to iruplinalkib treatment based on clinical judgment, temporal association, and alternative etiologies. Events assessed as possibly, probably, or definitely related to iruplinalkib will be classified as treatment-related adverse reactions (TRAEs). The TRAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, 5.0). Serious adverse events (SAEs) will be identified and recorded in accordance with standard definitions or are considered medically significant by the investigator.
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.
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  1. Population: Male or female patients aged ≥18 years.
  2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.
  3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).
  4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.
  5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.
  6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.
  7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).

  1. 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.
  2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).
  3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.
  4. Pregnancy: Pregnant or breastfeeding women.
  5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).
Peking University Shenzhen Hospital logoPeking University Shenzhen Hospital
責任者
Fen Wang, 主任研究者, Associate chief physician, Peking University Shenzhen Hospital
試験中央連絡先
連絡先: FEN WANG, +86 13510331485, [email protected]
1 1カ国の場所

Guangdong

Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518000, China
FEN WANG, 連絡先, +86 13692291485, [email protected]
募集中