NCT07361237

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tongji University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	HJ-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.

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China