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 (May 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
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)
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.
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