RecruitingPhase 1NCT07361237

A Phase l Clinical Study to Evalute the Safety,Tolerability,Pharmacokinetic Characteristics,and Preliminary Anti-tumor Efficacy of HJ-004-02 Tablets in Patients With Non-squamous Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations


Sponsor

Tongji University

Enrollment

36 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Single dose: Fasting, oral administration, as a single dose, taken with warm water. Multiple doses: Fasting, oral administration, as a single dose, taken with warm water, once daily (dosing frequency may be adjusted based on study data), with 28 days as one cycle.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called HJ-004-02 for people with a specific type of non-small cell lung cancer (NSCLC) that has a mutation in a gene called EGFR, to evaluate its safety, how the body processes it, and early signs of effectiveness. **You may be eligible if...** - You are 18–74 years old - You have been diagnosed with non-squamous non-small cell lung cancer - Your tumor has one or more EGFR gene mutations - Your cancer has progressed after standard treatments, or you cannot tolerate them - You are well enough to carry out daily activities (ECOG 0–1) - Your blood counts and organ function are within safe ranges - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have squamous cell lung cancer - Your cancer does not have an EGFR mutation - You have active brain metastases that require treatment - You are pregnant or breastfeeding - Your organ function (kidneys, liver, blood) does not meet minimum thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHJ-004-02 tablets

Single dose: Fasting, oral administration, as a single dose, taken with warm water. Multiple doses: Fasting, oral administration, as a single dose, taken with warm water, once daily (dosing frequency may be adjusted based on study data), with 28 days as one cycle.


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07361237


Related Trials