An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer

NCT06693336 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 132551-1
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 2

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.

Conditions

Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)

Keywords

NSCLC; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability)

  Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

  Day 1 to 52 weeks

Secondary Outcomes (1)

• Incidence of local tumour recurrence

  1 year

Other Outcomes (1)

• Disease free survival (DFS)

  1 year

Study Arms (1)

Dose Escalation and Confirmation

EXPERIMENTAL

All participants will receive a one-time administration of SMS001 undergoing their scheduled lung cancer surgery. Participants are given SMS001 and are watched very closely for side effects. If the side effects are manageable, then more participants are asked to join the study and are given a higher dose of SMS001, until a pre-defined suitable dose is reached.

Drug: SMS001

Interventions

SMS001 DRUG

One time administration

Also known as: Paclitaxel

Dose Escalation and Confirmation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Normal liver, and renal function at study entry
• Laboratory requirements:
• WBC \> 2500/mm3
• Neutrophil \>1500/mm3
• Hemoglobin \>10 g/dL
• Platelet \>100,000/ mm3
• AST and ALT \< 2.5 x ULN
• Total bilirubin \< 1.5 x ULN
• Creatinine \< 2 mg/dL (equivalent to 176.8 μmol/L)
• Normal PT/INR and PTT
• eGFR \>60mL/min/1.73m²

You may not qualify if:

• If a subject meets any of the following criteria, he/she must be excluded from the study.
• 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.
• Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery.
• 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.
• Pregnant or nursing female subjects.
• Unwilling or unable to follow protocol requirements.
• 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.

Sponsors & Collaborators

• ToLymph Inc.: lead
• Toronto General Hospital / University Health Network (UHN): collaborator
• Mayo Clinic, Rochester, MN: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Kazuhiro Yasufuku MD, PhD, FRCSC

  Toronto General Hospital / University Health Network (UHN)

  PRINCIPAL INVESTIGATOR

• Janani S Reisenauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lister / Clinical Research Coordinator / UHN

CONTACT

1-416-340-4857; jennifer.lister@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)