Actively Recruiting
An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
Led by ToLymph Inc. · Updated on 2026-03-06
42
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
Sponsors
T
ToLymph Inc.
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological confirmation of NSCLC
- Stage Ib, IIa, IIb, or IIIa (N2) lung cancer according to AJCC 8th edition
- Age 18 years or older and suitable for lung cancer surgery
- No prior chemotherapy or thoracic radiation therapy
- Normal liver and kidney function at study entry
- Laboratory values: WBC > 2500/mm3, Neutrophil >1500/mm3, Hemoglobin >10 g/dL, Platelet >100,000/mm3
- AST and ALT less than 2.5 times upper limit of normal
- Total bilirubin less than 1.5 times upper limit of normal
- Creatinine less than 2 mg/dL
- Normal PT/INR and PTT coagulation tests
- Estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73m2
- QTcF interval: males less than 450 msec, females less than 470 msec
- Candidate for complete lung cancer surgical resection and lymph node removal
- Willingness and availability to comply with all study procedures
- Ability to understand and sign informed consent
- Women of childbearing potential must use highly effective contraception for at least 6 months after treatment
- Men must use highly effective contraception for at least 3 months after treatment
You will not qualify if you...
- Evidence of locally advanced T3 or T4 NSCLC or distant metastasis
- Need for pneumonectomy or sleeve lung resection
- Known allergy or sensitivity to any components of the study drug
- History of other cancers within the last 5 years except non-melanoma skin cancer
- Received induction chemotherapy or radiation before surgery
- Uncontrolled illnesses such as active infections, organ dysfunction, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting study compliance
- Pregnant or nursing women
- Unwilling or unable to follow study protocol
- Any other condition that may interfere with compliance or study visits as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
J
Jennifer Lister / Clinical Research Coordinator / UHN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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