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

Last updated: November 20, 2024
Sponsor: ToLymph Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

SMS001

Clinical Study ID

NCT06693336
132551-1
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Histopathological confirmed NSCLC

  2. Stage Ib, IIa, IIb or IIIa (N2) for both dose escalation and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)

  3. Age ≥18 years and suitable for lung cancer surgery

  4. No prior chemotherapy and/or thoracic radiation therapy

  5. Normal liver, and renal function at study entry

  6. Laboratory requirements:

  7. WBC > 2500/mm3

  8. Neutrophil >1500/mm3

  9. Hemoglobin >10 g/dL

  10. Platelet >100,000/ mm3

  11. AST and ALT < 2.5 x ULN

  12. Total bilirubin < 1.5 x ULN

  13. Creatinine < 2 mg/dL (equivalent to 176.8 μmol/L)

  14. Normal PT/INR and PTT

  15. eGFR >60mL/min/1.73m²

  16. QT interval corrected for heart rate using Frederica's formula (QTcF): males < 450msec and females < 470msec

  17. Operating surgeon deems patient is candidate for complete surgical resection of lungcancer and lymphadenectomy or lymph node sampling (Wedge resection, segmentectomy orlobectomy are acceptable)

  18. Stated willingness to comply with all study procedures and availability for theduration of the study

  19. Ability to understand and sign informed consent

  20. Women of childbearing potential (WOCBP) must use highly effective methods ofcontraception for at least 6 months after wafer insertion. Otherwise, women must bepostmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmedby follicle stimulating hormone [FSH] ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 ypostmenopausal) or be surgically sterile. Men must use highly effective methods ofcontraception for at least 3 months after wafer insertion. Examples of highlyeffective contraception include: parenteral contraceptives, oral contraceptives,patch contraceptives, implantable hormonal contraceptives, intrauterine device orsystem, surgical sterilization (hysterectomy, bilateral oophorectomy, and/orbilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexualabstinence, if this is the subject's current practice. Periodic abstinence, i.e.,calendar, symptothermal, or post-ovulation methods are not an acceptable form ofcontraception for this study.

Exclusion

Exclusion Criteria:

If a subject meets any of the following criteria, he/she must be excluded from the study.

  1. Evidence of locally advanced T3 or T4 NSCLC or distant metastatic disease.

  2. Patients requiring pneumonectomy or sleeve resection.

  3. Known sensitivity to any of the study agent components.

  4. Patients with a previous malignancy within the last 5 years except non-melanoma skincancer.

  5. Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior tosurgery.

  6. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection. dysfunction of major organ (e.g., liver, kidney etc.), symptomaticcongestive heart failure. unstable angina pectoris, cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements.

  7. Pregnant or nursing female subjects.

  8. Unwilling or unable to follow protocol requirements.

  9. Any other condition (e.g., psychiatric disorder) that, in the opinion of theInvestigator, may interfere with the patient's ability to comply with the studyrequirements or visit schedule.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: SMS001
Phase: 2
Study Start date:
November 18, 2024
Estimated Completion Date:
October 30, 2026

Study 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.

Connect with a study center

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

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