RecruitingPhase 2NCT06693336

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


Sponsor

ToLymph Inc.

Enrollment

42 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new formulation of paclitaxel — a standard chemotherapy drug — delivered as a biodegradable wafer implanted directly into the chest after lung surgery, rather than given intravenously. The goal is to provide localized chemotherapy to reduce the risk of the cancer coming back after surgery in patients with early-stage non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are 18 years or older - You have been diagnosed with non-small cell lung cancer (confirmed by biopsy) at stage Ib, IIa, IIb, or IIIa - You have not received any prior chemotherapy or chest radiation - Your surgeon considers you a candidate for complete surgical removal of the cancer - Your blood counts, liver, and kidney functions are within acceptable ranges - You are willing to comply with all study procedures **You may NOT be eligible if...** - You have previously received chest chemotherapy or radiation - Your heart's electrical activity (QT interval) is abnormal - Your organ function does not meet required lab values - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSMS001

One time administration


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

Toronto General Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06693336


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