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New pill aims to stop lung cancer return after surgery

NCT ID NCT07330076

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests iruplinalkib tablets as a daily treatment after surgery for people with stage IA ALK-positive non-small cell lung cancer who have high-risk factors. The goal is to see if the drug can prevent the cancer from coming back. About 28 participants will take the pill for up to 2 years, and researchers will track how many remain cancer-free after 3 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iruplinalkib tablets
What this could lead to
If successful, this could provide a new treatment option to reduce the risk of cancer returning after surgery for early-stage ALK-positive lung cancer.
What could go wrong
This is a small, early-phase trial with only 28 participants, so results may not apply to all patients. The drug may cause side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- 1.Age ≥18 years, male or female. 2.ECOG Performance Status (PS) score: 0-1. 3.Expected survival ≥12 weeks. 4.Histologically or cytologically confirmed non-small cell lung cancer. 5.ALK-positive status confirmed by the investigator (NGS). 6.Clinical stage IA (maximum tumor diameter ≤3 cm, AJCC 9th edition). 7.No prior treatment with any ALK TKI targeted therapy. 8.The patient has undergone curative-intent tumor resection (sublobar resection, lobectomy, sleeve resection). 9.Organ function meets the following requirements (use of any blood products or hematopoietic growth factors within 14 days prior to enrollment is not allowed): * Hemoglobin ≥90 g/L; * White blood cell count ≥3.5 × 10⁹/L; * Absolute neutrophil count ≥1.5 × 10⁹/L; * Platelets ≥80 × 10⁹/L; * AST, ALT ≤2.5 × ULN; if liver metastases are present, AST, ALT ≤5 × ULN; * Total bilirubin (TBIL) ≤1.5 × ULN; * Urea/BUN and creatinine (Cr) ≤1.5 × ULN (and creatinine clearance (CCr) ≥50 mL/min); * Left ventricular ejection fraction (LVEF) ≥50%. 10.Patients of childbearing potential/fertile males must agree to use effective contraception. Exclusion Criteria: * 1.Presence of pathological components other than non-small cell carcinoma in tissue or cytology. 2\. History of allergy to ALK TKI agents or their ingredients. 3. Poorly controlled underlying diseases before enrollment, such as coronary artery disease, heart failure, cerebral infarction, hypertension, chronic obstructive pulmonary disease, interstitial lung disease, rheumatic diseases, peptic ulcer, etc. (to be determined by the investigator's assessment). 4\. Active pulmonary tuberculosis (TB), active tuberculosis infection, or active syphilis infection; eligibility for the clinical trial may be reassessed after the condition is stably controlled. 5\. Positive anti-HIV test; positive hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal; active hepatitis C virus (HCV) infection. 6\. Serious infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C). 7\. Psychiatric disorders or social conditions that limit the subject's compliance with study requirements or affect their ability to provide written informed consent. 8\. Any arterial thromboembolic event within 6 months prior to the first dose, venous thromboembolic events of Grade 3 or above, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 3 months prior to the first dose. 9\. History of severe bleeding tendency or coagulation dysfunction; obvious active bleeding within 1 month prior to the first dose (to be determined by the investigator's assessment). 10\. History of drug abuse, alcohol abuse, or substance abuse. 11. Pregnant or lactating women. 12. Patients deemed unsuitable for participation in this study by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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