NCT06693336

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: ToLymph Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	SMS001	One time administration

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-11-18
• Completion: 2026-12-30
• First posted: 2024-11-18
• Last updated: 2026-03-06

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study