An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer

Inclusion Criteria

• •1. Histopathological confirmed NSCLC
• •2. Stage Ib, IIa, IIb or IIIa (N2) for both dose escalation and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)
• •3. Age ≥18 years and suitable for lung cancer surgery
• •4. No prior chemotherapy and/or thoracic radiation therapy
• •5. Normal liver, and renal function at study entry
• •6. Laboratory requirements:
• •1. WBC \> 2500/mm3
• •2. Neutrophil \>1500/mm3
• •3. Hemoglobin \>10 g/dL
• •4. Platelet \>100,000/ mm3
• •5. AST and ALT \< 2.5 x ULN
• •6. Total bilirubin \< 1.5 x ULN
• •7. Creatinine \< 2 mg/dL (equivalent to 176.8 μmol/L)
• •8. Normal PT/INR and PTT
• •9. eGFR \>60mL/min/1.73m²
• •7. QT interval corrected for heart rate using Frederica's formula (QTcF): males \< 450msec and females \< 470msec
• •8. Operating surgeon deems patient is candidate for complete surgical resection of lung cancer and lymphadenectomy or lymph node sampling (Wedge resection, segmentectomy or lobectomy are acceptable)
• •9. Stated willingness to comply with all study procedures and availability for the duration of the study
• •10. Ability to understand and sign informed consent
• •11. Women of childbearing potential (WOCBP) must use highly effective methods of contraception for at least 6 months after wafer insertion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 y postmenopausal) or be surgically sterile. Men must use highly effective methods of contraception for at least 3 months after wafer insertion. Examples of highly effective contraception include: parenteral contraceptives, oral contraceptives, patch contraceptives, implantable hormonal contraceptives, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the subject's current practice. Periodic abstinence, i.e., calendar, symptothermal, or post-ovulation methods are not an acceptable form of contraception for this study.