Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib (SAILOR)

January 24, 2026 updated by: Fen Wang, Peking University Shenzhen Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
Drug: Iruplinalkib tablets
180mg, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-World Progression-Free Survival (rwPFS)
Time Frame: 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.
From index date through study completion, an average of 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Next Treatment (TTNT)
Time Frame: From index date to the start of next line of therapy, assessed up to 36 months
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)
Time Frame: From index date through study completion, an average of 36 months
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 )
Time Frame: 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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-World Objective Response Rate (rwORR)
Time Frame: From index date until disease progression or start of new anti-cancer therapy, assessed up to 36 months
rwORR is defined as the proportion of patients with a best overall response (BOR) of real-world complete response (rwCR) or real-world partial response (rwPR) as documented in the electronic health records (EHR). Response assessment is based on the treating clinician's qualitative assessment in clinical notes (clinician-anchored) and/or radiology reports, without strictly requiring RECIST 1.1 measurements. Patients without sufficient data to assess response are considered non-responders.
From index date until disease progression or start of new anti-cancer therapy, assessed up to 36 months
Real-World Disease Control Rate (rwDCR)
Time Frame: from index date until disease progression or start of new anti-cancer therapy, assessed up to 36 months
rwDCR is defined as the proportion of patients with a best overall response (BOR) of real-world complete response (rwCR), real-world partial response (rwPR), or real-world stable disease (rwSD). To be classified as rwSD, the condition must be maintained for a minimum duration (e.g., at least 6 weeks) from the index date. Assessment is derived from unstructured clinical notes (clinician-anchored).
from index date until disease progression or start of new anti-cancer therapy, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Shenzhen Hospital

Collaborators

The First Affiliated Hospital of Guangzhou Medical University
Shenzhen People's Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University Cancer Hosptial
Longgang District People's Hospital of Shenzhen
People Hospital of New District Longhua Shenzhen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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