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:

7. WBC > 2500/mm3

8. Neutrophil >1500/mm3

9. Hemoglobin >10 g/dL

10. Platelet >100,000/ mm3

11. AST and ALT < 2.5 x ULN

12. Total bilirubin < 1.5 x ULN

13. Creatinine < 2 mg/dL (equivalent to 176.8 μmol/L)

14. Normal PT/INR and PTT

15. eGFR >60mL/min/1.73m²

16. QT interval corrected for heart rate using Frederica's formula (QTcF): males < 450msec and females < 470msec

17. Operating surgeon deems patient is candidate for complete surgical resection of lungcancer and lymphadenectomy or lymph node sampling (Wedge resection, segmentectomy orlobectomy are acceptable)

18. Stated willingness to comply with all study procedures and availability for theduration of the study

19. Ability to understand and sign informed consent

20. Women of childbearing potential (WOCBP) must use highly effective methods ofcontraception for at least 6 months after wafer insertion. Otherwise, women must bepostmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmedby follicle stimulating hormone [FSH] ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 ypostmenopausal) or be surgically sterile. Men must use highly effective methods ofcontraception for at least 3 months after wafer insertion. Examples of highlyeffective contraception include: parenteral contraceptives, oral contraceptives,patch contraceptives, implantable hormonal contraceptives, intrauterine device orsystem, surgical sterilization (hysterectomy, bilateral oophorectomy, and/orbilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexualabstinence, if this is the subject's current practice. Periodic abstinence, i.e.,calendar, symptothermal, or post-ovulation methods are not an acceptable form ofcontraception for this study.

Exclusion Criteria:

If a subject meets any of the following criteria, he/she must be excluded from the study.

1. Evidence of locally advanced T3 or T4 NSCLC or distant metastatic disease.

2. Patients requiring pneumonectomy or sleeve resection.

3. Known sensitivity to any of the study agent components.

4. Patients with a previous malignancy within the last 5 years except non-melanoma skincancer.

5. Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior tosurgery.

6. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection. dysfunction of major organ (e.g., liver, kidney etc.), symptomaticcongestive heart failure. unstable angina pectoris, cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements.

7. Pregnant or nursing female subjects.

8. Unwilling or unable to follow protocol requirements.

9. Any other condition (e.g., psychiatric disorder) that, in the opinion of theInvestigator, may interfere with the patient's ability to comply with the studyrequirements or visit schedule.