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Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors | Clinical Trials | Clareo Health

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Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors

Protocol for a Prospective, Single-arm, Multicenter Clinical Study on the Efficacy and Safety of Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors

NCT07330076•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

The primary objective is to evaluate the efficacy and safety of Iruplinalkib Tablets as postoperative adjuvant therapy in patients with stage IA, ALK-positive NSCLC with high-risk factors.

Detailed Description

This Prospective, Single-arm, Multicenter Clinical Study aims to evaluate the Efficacy and Safety of Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC with High-risk Factors.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

January 6, 2026

Primary Completion Date

December 31, 2030

Completion Date

December 31, 2031

Last Updated

January 9, 2026

Enrollment

ESTIMATED participants

Conditions

NSCLC

Interventions

Iruplinalkib tablets

DRUG

Contacts

Chenguang Li, M.D

CONTACT

+8618622819082 cgli82@yeah.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors

Inclusion Criteria

Exclusion Criteria

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