Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
Conditions
Keywords
NSCLC, Carcinoma
Brief 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.
Detailed 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.
Interventions
DRUGSMS001
One time administration
Sponsors
ToLymph Inc.
University Health Network, Toronto
Mayo Clinic, Rochester, MN
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 (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.
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 skin cancer. 5. Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection. dysfunction of major organ (e.g., liver, kidney etc.), symptomatic congestive heart failure. unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 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 the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability) | Day 1 to 52 weeks | Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of local tumour recurrence | 1 year | Time from SMS001 treatment to any clinically, histologically or radiologically confirmed local recurrence of NSCLC to mediastinal lymph nodes |
Countries
Canada, United States
Contacts
CONTACTJennifer Lister / Clinical Research Coordinator / UHN
PRINCIPAL_INVESTIGATORKazuhiro Yasufuku MD, PhD, FRCSC
University Health Network, Toronto
PRINCIPAL_INVESTIGATORJanani S Reisenauer, MD
Mayo Clinic
Outcome results
None listed