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 Ia-IIIa (N2) Non-Small Cell Lung Cancer (NSCLC) Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests SMS001, a new form of the cancer drug paclitaxel, in adults with non-small cell lung cancer who can have surgery. Doctors want to find a safe dose and see how well it treats the cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with non-small cell lung cancer confirmed by a tissue test.
- Cancer is stage IA, IB, IIA, IIB, or IIIA (N2). These stages describe how far the cancer has grown or spread.
- A surgeon believes all the cancer can be removed, with nearby lymph nodes removed or sampled.
- No past chemotherapy or radiation treatment to the chest.
- Normal liver and kidney function. Blood cell counts, blood clotting, and other lab tests must meet study limits.
- A heart test must show a QTcF—a measure of the heart's electrical timing—below 450 milliseconds for men or 470 for women.
- Able to understand and sign the consent form, follow study steps, and take part for the full study.
- Women who can become pregnant must use highly effective birth control for at least 6 months after the drug wafer is placed. Men must use it for at least 3 months. Other women must meet the study's rules for menopause or surgery that prevents pregnancy.
Who can't join
- Cancer is T3 or T4, meaning it has grown farther into nearby areas, or has spread to distant parts of the body.
- Need surgery to remove a whole lung, or a sleeve resection, which removes part of an airway along with lung tissue.
- Known sensitivity to any part of the study drug.
- Another cancer within the past 5 years, except non-melanoma skin cancer.
- Receiving chemotherapy or radiation before surgery to prepare for surgery.
- An uncontrolled illness, such as an active infection, major organ problems, or certain heart problems.
- Pregnant or breastfeeding.
- Unable or unwilling to follow study rules or attend visits, including because of mental health problems, social issues, or another condition.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Histopathological confirmed NSCLC 2. 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) 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.
Study sites (1)
MN
- Mayo Clinic · Rochester, MN 55905Pierson Karlyn · Study contact · 877-526-9172 · pierson.karlyn@mayo.eduJanani S Reisenauer, MD · Principal investigatorMore trials in Rochester