Evaluating a new drug for lung cancer treatment

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

This study is testing a new drug called SMS001 to see if it is safe and helps people with non-small cell lung cancer who are having surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: ToLymph Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Rochester, Minnesota and 1 other locations)
• Trial ID: NCT06693336 on ClinicalTrials.gov

What this trial studies

This study evaluates SMS001, a new formulation of Paclitaxel, in patients with Non-Small Cell Lung Cancer (NSCLC) who are undergoing surgery. The primary objective is to determine the safety and tolerability of SMS001, while secondary objectives include assessing tumor recurrence and disease-free survival at a 12-month follow-up. Patients will receive a predefined dose of SMS001, and their health will be monitored closely throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed NSCLC at stages Ib, IIa, IIb, or IIIa who are suitable for surgical resection.

Not a fit: Patients with prior chemotherapy or thoracic radiation therapy, or those with significant comorbidities affecting liver or renal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with NSCLC, potentially improving their survival rates.

How similar studies have performed: Other studies have shown promise with similar approaches using Paclitaxel in lung cancer treatment, indicating potential for success.

Eligibility criteria

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:

   1. WBC \> 2500/mm3
   2. Neutrophil \>1500/mm3
   3. Hemoglobin \>10 g/dL
   4. Platelet \>100,000/ mm3
   5. AST and ALT \< 2.5 x ULN
   6. Total bilirubin \< 1.5 x ULN
   7. Creatinine \< 2 mg/dL (equivalent to 176.8 μmol/L)
   8. Normal PT/INR and PTT
   9. eGFR \>60mL/min/1.73m²
7. QT interval corrected for heart rate using Frederica's formula (QTcF): males \< 450msec and females \< 470msec
8. Operating surgeon deems patient is candidate for complete surgical resection of lung cancer and lymphadenectomy or lymph node sampling (Wedge resection, segmentectomy or lobectomy are acceptable)
9. Stated willingness to comply with all study procedures and availability for the duration of the study
10. Ability to understand and sign informed consent
11. Women of childbearing potential (WOCBP) must use highly effective methods of contraception for at least 6 months after wafer insertion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 y postmenopausal) or be surgically sterile. Men must use highly effective methods of contraception for at least 3 months after wafer insertion. Examples of highly effective contraception include: parenteral contraceptives, oral contraceptives, patch contraceptives, implantable hormonal contraceptives, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the subject's current practice. Periodic abstinence, i.e., calendar, symptothermal, or post-ovulation methods are not an acceptable form of contraception for this study.

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 skin cancer.
5. Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery.
6. 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.
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 the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule.

Where this trial is running

Rochester, Minnesota and 1 other locations

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Kazuhiro Yasufuku MD, PhD, FRCSC — University Health Network, Toronto
• Study coordinator: Jennifer Lister / Clinical Research Coordinator / UHN

Conditions Carcinoma, Non-Small-Cell Lung Cancer; NSCLC; Carcinoma