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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji University

About this trial

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 criteria

Qualifiers

Male or female, aged >=18 years and <75 years

Clinical diagnosis of NSCLC.

Subjects must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy.

Subjects must provide 3-5 archived tumor tissue slides

Disqualifiers

Within the four weeks prior to the administration of HJ-004-02 tablets, the patient had received other anti-tumor treatments such as biological therapy, immunotherapy, radiotherapy, and chemotherapy.

Participation in an investigational drug study with treatment or use of an investigational device within 4 weeks before the first dose of HJ-004-02 tablets. 3. Anticipated need for any other form of anti-tumor therapy during the study.

Trial design

Treatments tested in this trial

  • HJ-004-02 tablets

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators