An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorToLymph Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Histopathological confirmed NSCLC
Stage Ib, IIa, IIb or IIIa (N2) for both dose escalation and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)
Age ≥18 years and suitable for lung cancer surgery
No prior chemotherapy and/or thoracic radiation therapy
Disqualifiers
Evidence of locally advanced T3 or T4 NSCLC or distant metastatic disease.
Patients requiring pneumonectomy or sleeve resection.
Known sensitivity to any of the study agent components.
Patients with a previous malignancy within the last 5 years except non-melanoma skin cancer.
Trial design
Treatments tested in this trial
- SMS001
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
ToLymph Inc.
Lead sponsor
University Health Network, Toronto
Collaborator
Mayo Clinic, Rochester, MN
Collaborator
Source ClinicalTrials.gov