Careseng 1370 for Chemotherapy-Induced Myelosuppression

Exclusion Criteria

• •1. Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit
• •2. Has undergone major surgery within 4 weeks before Screening visit
• •3. With contraindications to MRI
• •4. Has elective or planned surgery to be conducted during the trial
• •5. Has documented brain or leptomeningeal metastases or any cancer other than NSCLC
• •6. Inadequate hematologic function, as defined by: absolute neutrophil count (ANC) ≤ 1,500/µL; hemoglobin concentration \< 10.0 g/dL; and platelet count ≤ 100,000/µL
• •7. Inadequate hepatic function, as defined by: total bilirubin level \> ULN; AST or ALT \> 1.5 x ULN; gamma-GT \> 2.5 x ULN; ALP \> 2.5 x ULN.
• •8. Inadequate renal function, as defined by: serum creatinine level \> 1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) \< 50 mL/min
• •9. Urinary protein \>1+ on dipstick, edema or serum albumin \< lower level of normal
• •10. Any other ≥ grade 3 laboratory abnormality at baseline
• •11. Inadequate coagulation function, as defined by: INR \> 1.5 x ULN or aPTT \> 1.5 x ULN
• •12. Male subject with female spouse/partners who are of childbearing potential refuses to adopt highly effective contraceptives from Screening visit until 7 days after end of study treatment
• •13. Female subjects with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating, refuses to adopt highly effective contraceptives, if heterosexually active, from Screening visit until 7 days after end of study treatment
• •14. Requirement of anticoagulants, antiplatelet treatments (e.g., warfarin, heparins) from Screening visit until Final visit
• •15. History of human immunodeficiency virus (HIV) infection
• •16. Has experienced any grade 3 or 4 gastrointestinal bleeding within 12 weeks before Screening visit
• •17. Has a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess \<6 months before Screening visit, or the subject has a history of poorly controlled or recurrent inflammatory bowel disease (including Crohn's disease or ulcerative colitis)
• •18. Has participated in a clinical study within 4 weeks prior to Screening visit
• •19. Has a known allergy to investigational product Careseng 1370, matched placebo, cisplatin, docetaxel or their excipients. If there is suspicion that the subject may have an allergy, the subject should be excluded.
• •20. Has known alcohol or drug dependency
• •21. Requirement for ongoing immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine) or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days
• •22. Significant cardiovascular disease, including:
• •1. History of New York Heart Association (NYHA) class III or IV congestive heart failure
• •2. Ongoing uncontrolled hypertension
• •3. History of congenital long QT syndrome
• •4. Ongoing prolonged corrected QT (QTc) interval defined as at least 450 msec
• •5. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
• •23. Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing per investigator's discretion
• •24. Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of cisplatin + docetaxel or Careseng 1370/matched placebo administration
• •25. Is not considered to be suitable for this study, in the opinion of the investigator