ToLymph Inc.
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
PRIMARY OBJECTIVES: 1\. To evaluate the safety and tolerability of SMS001 in Non-Small Cell Lung Cancer (NSCLC) patients undergoing cancer surgery. SECONDARY OBJECTIVES: 1. To evaluate tumor recurrence at 12-month follow-up in NSCLC lung cancer patients treated at a predefined dose. 2. To evaluate disease free survival (DFS) for patients treated with SMS001 at the end of study.
Inclusion Criteria: 1. Histopathological confirmed NSCLC 2. Stage Ia, 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 (equ…
One time administration
Arctuva estimate
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