Non-Small Cell Lung CancerSAILORNCT07374614
Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
An observational study of Non-Small Cell Lung Cancer and ALK, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, ALK, Iruplinalkib
- What is being tested?
- Iruplinalkib tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALK-positive lung adenocarcinoma patients who receive Iruplinalkib after lorlatinib treatment.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
FEN WANG, +86 13692291485, fina_wang@163.com
About this study
Official title: An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment
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.
Read the detailed description
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:
This study is designed as an observational investigation to assess the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have received prior lorlatinib treatment. The study will include eligible patients who are prescribed iruplinalkib as part of routine clinical practice. This study aims to characterize the clinical benefit of iruplinalkib and explore its potential role as a subsequent-line treatment option in this specific population.
- Conditions
- Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Lorlatinib, Real-world Study, Observational Study
- Being tested
- Iruplinalkib tablets
- Keywords
- Iruplinalkib, ALK-postive, Post-Lorlatinib, Advanced Lung Adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iruplinalkib tabletsDrug
180mg, QD
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Not described Receives: Drug: Iruplinalkib tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From index date through study completion, an average of 36 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen People's Hospital, Longgang District People's Hospital of Shenzhen, Sun Yat-Sen University Cancer Center, Eighth Affiliated Hospital, Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University, People Hospital of New District Longhua Shenzhen
- Responsible party
- Principal investigator, Fen Wang, Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374614
- Sponsor's protocol ID
- 2025-324
- Acronym
- SAILOR
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi 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.
PubMed 35087031Camidge 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.
PubMed 32780660Mok 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.
PubMed 32418886Zhang 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.
PubMed 27780853Solomon 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.
PubMed 25470694Raskova Kafkova L, Mierzwicka JM, Chakraborty P, Jakubec P, Fischer O, Skarda J, Maly P, Raska M. NSCLC: from tumorigenesis, immune checkpoint misuse to current and future targeted therapy. Front Immunol. 2024 Feb 7;15:1342086. doi: 10.3389/fimmu.2024.1342086. eCollection 2024.
PubMed 38384472Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751