Clinical trial · Observational
Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment
NCT07374614CI-TRIAL-00101954SAILORrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK | — | UNRESOLVED | — |
| Iruplinalkib | — | UNRESOLVED | — |
| Lorlatinib | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Observational Study | — | UNRESOLVED | — |
| Real-world Study | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iruplinalkib tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment group
- interventionNames
- Drug: Iruplinalkib tablets
Primary outcomes (1)
- measure
- Real-World Progression-Free Survival (rwPFS)
- timeFrame
- From index date through study completion, an average of 36 months
- description
- 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.
Secondary outcomes (3)
- measure
- Time to Next Treatment (TTNT)
- timeFrame
- From index date to the start of next line of therapy, assessed up to 36 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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). Exclusion Criteria: 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).
References
Publications (7)
- RESULTShi Y, Fang J, Hao X, Zhang S, Liu Y, Wang L, Chen J, Hu Y, Hang X, Li J, Liu C, Zhang Y, Wang Z, Hu Y, Gu K, Huang J, Zhang L, Shan J, Ouyang W, Zhao Y, Zhuang W, Yu Y, Zhao J, Zhang H, Lu P, Li W, Si M, Ge M, Geng H. Safety and activity of WX-0593 (Iruplinalkib) in patients with ALK- or ROS1-rearranged advanced non-small cell lung cancer: a phase 1 dose-escalation and dose-expansion trial. Signal Transduct Target Ther. 2022 Jan 28;7(1):25. doi: 10.1038/s41392-021-00841-8. PMID 35087031
- RESULTCamidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11. PMID 32780660
- RESULTMok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Perol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanovic V, Hilton M, Ruf T, Noe J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11. PMID 32418886
- RESULTZhang S, Anjum R, Squillace R, Nadworny S, Zhou T, Keats J, Ning Y, Wardwell SD, Miller D, Song Y, Eichinger L, Moran L, Huang WS, Liu S, Zou D, Wang Y, Mohemmad Q, Jang HG, Ye E, Narasimhan N, Wang F, Miret J, Zhu X, Clackson T, Dalgarno D, Shakespeare WC, Rivera VM. The Potent ALK Inhibitor Brigatinib (AP26113) Overcomes Mechanisms of Resistance to First- and Second-Generation ALK Inhibitors in Preclinical Models. Clin Cancer Res. 2016 Nov 15;22(22):5527-5538. doi: 10.1158/1078-0432.CCR-16-0569. Epub 2016 Oct 25. PMID 27780853
- RESULTSolomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440.