OncoMatch/Clinical Trials/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
Is NCT07361237 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies HJ-004-02 tablets for nsclc (advanced non-small cell lung cancer).
Treatment: 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation
Subjects must have non-squamous NSCLC with one or more positive EGFR mutations
Excluded: ALK abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: HER2 (ERBB2) abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: KRAS abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: ROS1 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: FGFR1 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: FGFR2 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: FGFR3 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: NTRK1 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: NTRK2 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: NTRK3 abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: RET abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Excluded: BRAF abnormality
Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: standard therapy
Subjects must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy.
Cannot have received: biological therapy
Exception: within the four weeks prior to the administration of HJ-004-02 tablets
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.
Cannot have received: immunotherapy
Exception: within the four weeks prior to the administration of HJ-004-02 tablets
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.
Cannot have received: radiation therapy
Exception: within the four weeks prior to the administration of HJ-004-02 tablets
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.
Cannot have received: cytotoxic chemotherapy
Exception: within the four weeks prior to the administration of HJ-004-02 tablets
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.
Lab requirements
Blood counts
ANC >= 1.5×10^9/L; Platelet count >= 100×10^9/L; Hemoglobin >=9.0 g/dL
Kidney function
Creatinine <=1.5 × ULN; if >1.5 × ULN, creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin (TBIL) <=1.5 × ULN; ALT and AST <=2.5 × ULN (<=5 × ULN with liver metastases)
(1) Hematologic Function: ANC >= 1.5×10^9/L; Platelet count >= 100×10^9/L; Hemoglobin >=9.0 g/dL; (2) Hepatic Function: TBIL <=1.5 × ULN; ALT and AST <=2.5 × ULN (<=5 × ULN with liver metastases); (3) Renal Function: Creatinine <=1.5 × ULN; if >1.5 × ULN, creatinine clearance ≥50 mL/min [Cockcroft-Gault formula]; (4) Coagulation Panel: INR <= 1.5×ULN; APTT <= 1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07361237 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior biological therapy, immunotherapy, radiation therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Are patients with ALK alterations eligible?
No. ALK abnormality is an exclusion criterion.
Are patients with ERBB2 alterations eligible?
No. ERBB2 abnormality is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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