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Tests treatment safety and results for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title 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
ClinicalTrials.gov ID: NCT07361237
What this study is testing
What is HJ-004-02 tablets?
HJ-004-02 tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female, aged \>=18 years and \<75 years
- Clinical diagnosis of NSCLC.
- people must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available...
- people must provide 3-5 archived tumor tissue slides
- people must have non-squamous NSCLC with one or more positive EGFR mutations
You likely can't join if
- Within the four weeks prior to the administration of HJ-004-02 tablets, the patient had received other anti-tumor treatments such as biological...
- 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...
See the full eligibility criteria
- Male or female, aged \>=18 years and \<75 years
- Clinical diagnosis of NSCLC.
- people must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy.
- people must provide 3-5 archived tumor tissue slides
- people must have non-squamous NSCLC with one or more positive EGFR mutations
- At least one measurable lesion according to RECIST v1.1 (In Phase Ia, lesions that are assessable but not measurable are acceptable).
- ECOG performance status score of 0-1
- Life expectancy \>=12 weeks.
- (1) Hematologic Function:Absolute neutrophil count (ANC) \>= 1.5×10\^9/L;Platelet count (PLT) \>= 100×10\^9/L;Hemoglobin (HGB) \>=9.0 g/dL; (2)Hepatic Function:Total bilirubin (TBIL) \ 1.5 × ULN, creatinine clearance...
- Contraception is required during the trial period.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.