Phase IIa Trial Evaluating the Safety and Therapeutic Effect of SMS001 as an Adjuvant Therapy to Control Tumor Recurrence in Stage Ib-IIIa (N2) Non-Small Cell Lung Cancer (NSCLC) Patients
ToLymph Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 (equival…
Interventions
- DrugSMS001
One time administration
Locations (2)
- Mayo ClinicRochester, Minnesota
- Toronto General HospitalToronto, Ontario