NCT07374614

Brief 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. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

January 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 16, 2026

Last Update Submit

January 24, 2026

Conditions

ALKIruplinalkibLorlatinibReal-world StudyNon-Small Cell Lung CancerObservational Study

Keywords

IruplinalkibALK-postivePost-LorlatinibAdvanced Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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.

Other Outcomes (2)

  • Real-World Objective Response Rate (rwORR)

    From index date until disease progression or start of new anti-cancer therapy, assessed up to 36 months

  • Real-World Disease Control Rate (rwDCR)

    from index date until disease progression or start of new anti-cancer therapy, assessed up to 36 months

Study Arms (1)

Treatment group

Drug: Iruplinalkib tablets

Interventions

Iruplinalkib tabletsDRUG

180mg, QD

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALK-positive lung adenocarcinoma patients who receive Iruplinalkib after lorlatinib treatment.

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 35087031RESULT

  • Camidge 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: 32780660RESULT

  • Mok 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: 32418886RESULT

  • Zhang 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: 27780853RESULT

  • Solomon 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.

    PMID: 25470694RESULT

  • Raskova 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.

    PMID: 38384472RESULT

  • Bray 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.

    PMID: 38572751RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

FEN WANG

CONTACT

+86 13510331485fina_wang@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 29, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)