A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients (NCT04001777) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
China80 participantsStarted 2019-07-04
Plain-language summary
There are unmet medical needs in patients who resist to EGFR TKIs, especially to osimertinib; APG-1252 shows synergy with osimertinib in both osimertinib treatment naïve and resistant cell lines. This study is to explore the safety and efficacy of the combination of APG-1252 and osimertinib in 3rd generation TKI resistant patients and 3rd generation TKI treatment naïve patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer.
✓. At least 1 measurable lesion (RECIST 1.1).
✓. Confirmed EGFR mutation positive before start use prior EGFR TKI(s) .
✓. Willing to biopsy or to supply achieved tumor sample which biopsy after the most recent treatment.
✓. Male or female patients age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
✓. Estimated OS ≥3 months.
✓. Adequate hematologic and bone marrow functions.
Exclusion criteria
✕. Received chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy (hormones for hypothyroidism or estrogen replacement therapy (ERT), anti-estrogen analogs, agonists required to suppress serum testosterone levels are permitted); or any investigational therapy; , or has had tumor embolization or tumor lysis syndrome (TLS) within 28 days prior to the first dose of study drug.
✕. Received TKIs targeted therapy (except third generation EGFR TKIs) within 14 days prior to the first dose of study drug.
✕. A history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
✕. Any of the following cardiac criteria: screening period resting period QTC \> 470 milliseconds (clinical electrocardiograph report value; if a single time\> 470 milliseconds, take the average of 3 inspections); rhythm of resting electrocardiogram (ECG), any clinically important abnormality of conduction or morphology (e.g., complete left bundle branch block, Grade 3 heart block, Grade 2 heart block); family history of congenital long QT prolongation syndrome or long QT syndrome.
✕. Evidence of any serious or uncontrolled systemic disease; various chronic active infections such as hepatitis B (HBV-DNA ≥ 104 copy number/ml or 2000 IU/ml), hepatitis C and HIV; uncontrollable Hypertensive patients (requires 2 or more drugs to control blood pressure); unstable angina; angina pectoris within 3 months prior to study; congestive heart failure (NYHA class II or higher); myocardial infarction (NSTEMI or STEMI) history in 6 months before study enrollment; severe arrhythmia requiring medical attention; severe liver, kidney, gastrointestinal or metabolic diseases.
✕. Patients who are unable to stop taking drugs or herbal medicine that are strong inhibitors or inducers of CYP3A within 1 week before the first study drug administration and during the treatment. However, patients who discontinue use of these compounds at least 1 week prior to receiving this regimen are eligible.
✕. Hemorrhagic constitution/disease, such as a history of non-chemotherapy-induced thrombocytopenic hemorrhage or a history of ineffective platelet transfusion within 1 year prior to the first dose of study drug; Severe gastrointestinal bleeding occurred within 3 months prior to the first dose of study drug; Active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA), etc.
✕. Use a therapeutic dose of anticoagulant or antiplatelet agent before the first use of APG-1252 or within 7 days of central catheter placement (if platelet count is stable (≧50×109/L), Subjects who previously received aspirin to prevent thrombosis therapy can reuse low-dose aspirin (i.e., up to 100 mg QD) after 3 weeks of study drug treatment; Decisions regarding anticoagulants and antiplatelet therapy will be determined by the investigator and the sponsor; Allow low-dose anticoagulant drugs to maintain central venous catheters open.