Study on SMS001 (Paclitaxel) for Treating Non-Small Cell Lung Cancer

Sponsor: ToLymph Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06693336

Provider View

This clinical trial is testing a new form of the drug Paclitaxel, called SMS001, to find a safe dose and see how well it works in treating patients with non-small cell lung cancer (NSCLC) who are undergoing surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of SMS001, a new version of the drug Paclitaxel, in patients with non-small cell lung cancer (NSCLC) who are having surgery. Researchers aim to determine a safe dose and assess how well the drug works in preventing cancer recurrence and improving survival without disease.

Description

The main goals of this study are to ensure that SMS001 is safe and well-tolerated in patients with non-small cell lung cancer (NSCLC) who are undergoing surgery. Researchers will also look at whether the cancer returns within 12 months after treatment and how long patients remain free of the disease by the end of the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC) at specific stages (Ib, IIa, IIb, or IIIa).
  • Aged 18 years or older and suitable for lung cancer surgery.
  • No previous chemotherapy or radiation therapy to the chest.
  • Normal liver and kidney function at the start of the study.
  • Meet specific blood test requirements, including:
    • White blood cell count over 2500/mm3.
    • Neutrophil count over 1500/mm3.
    • Hemoglobin level over 10 g/dL.
    • Platelet count over 100,000/mm3.
    • Liver enzymes (AST and ALT) less than 2.5 times the upper limit of normal.
    • Total bilirubin less than 1.5 times the upper limit of normal.
    • Creatinine less than 2 mg/dL.
    • Normal blood clotting times.
    • Estimated kidney function (eGFR) over 60 mL/min/1.73m².
  • Heart's QT interval within normal limits for males and females.
  • Surgeon believes the patient is a candidate for complete surgical removal of lung cancer.
  • Willingness to follow all study procedures and be available for the study duration.
  • Ability to understand and sign informed consent.
  • Women of childbearing potential must use effective contraception for at least 6 months after treatment. Men must use effective contraception for at least 3 months after treatment.

Exclusion Criteria

  • Have advanced lung cancer (T3 or T4) or cancer that has spread to other parts of the body.
  • Require major lung surgery like pneumonectomy or sleeve resection.
  • Known allergy to any components of the study drug.
  • Have had another cancer in the last 5 years, except for non-melanoma skin cancer.
  • Have received chemotherapy or radiation before surgery.
  • Have uncontrolled health issues, such as ongoing infections, major organ dysfunction, heart failure, unstable chest pain, irregular heartbeats, or psychiatric conditions that would affect study participation.
  • Pregnant or breastfeeding women.
  • Unwilling or unable to follow study requirements.
  • Any other condition that may interfere with the ability to comply with the study, as determined by the investigator.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic55905RochesterMinnesota

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