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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 80 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• Histopathological confirmed NSCLC
• Stage Ia, Ib, IIa, IIb or IIIa (N2) for both dose escalation and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)
• Age ≥18 years and suitable for lung cancer surgery
• No prior chemotherapy and/or thoracic radiation therapy
• Normal liver, and renal function at study entry
• Laboratory requirements:
• WBC > 2500/mm3
• Neutrophil >1500/mm3
• Hemoglobin >10 g/dL
• Platelet >100,000/ mm3
• AST and ALT < 2.5 x ULN
• Total bilirubin < 1.5 x ULN
• Creatinine < 2 mg/dL (equivalent to 176.8 μmol/L)
• Normal PT/INR and PTT
• eGFR >60mL/min/1.73m²
• QT interval corrected for heart rate using Frederica's formula (QTcF): males < 450msec and females < 470msec
• 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)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Ability to understand and sign informed consent
• 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.

You cannot join if

• If a subject meets any of the following criteria, he/she must be excluded from the study.
• Evidence of locally advanced T3 or T4 NSCLC or distant metastatic disease.
• Patients requiring pneumonectomy or sleeve resection.
• Known sensitivity to any of the study agent components.
• Patients with a previous malignancy within the last 5 years except non-melanoma skin cancer.
• Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery.
• 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.
• Pregnant or nursing female subjects.
• Unwilling or unable to follow protocol requirements.
• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

carboplatin/paclitaxel regimen. A regimen consisting of carboplatin and paclitaxel that may be used for the treatment of breast, kidney, cervical, vulvar, endometrial, ovarian, fallopian tube, primary peritoneal, head and neck, including cancer of the nasopharynx, esophageal and esophagogastric junction, and gastric cancers; non-small cell lung cancer (NSCLC); anaplastic carcinoma; anal, small bowel and non-urothelial and urothelial bladder cancer; salivary gland, malignant germ cell and malignant sex cord-stromal tumors; cutaneous and uveal melanoma; squamous cell skin cancer; thymomas and thymic carcinoma; occult primary adenocarcinoma or squamous cell carcinoma. Paclitaxel/carboplatin every 21 days regimen may be used for the treatment of esophageal and esophagogastric junction, and gastric cancers. NCI Drug Dictionary

Treatments listed in the registry

• SMS001 (Drug): One time administration

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• surgery: Part of the study plan

Main goals

• Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability) (Day 1 to 52 weeks)

Other goals

• Incidence of local tumour recurrence

Planned enrollment: 42 (estimated).

• Mayo Clinic, Rochester, Minnesota

1 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06693336
• NCI Drug Dictionary: C1411

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 23, 2026. Public record; not medical advice.