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New treatment option for Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
Official title An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06693336
What this study is testing
What is SMS001?
SMS001 is an investigational medicine, being studied as a potential treatment for carcinoma, non-small-cell lung cancer (nsclc).
Also referred to as Paclitaxel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Histopathological confirmed NSCLC
- Stage 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
You likely can't 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.
See the full eligibility criteria
- Histopathological confirmed NSCLC
- Stage 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...
- 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...
- Pregnant or nursing female people.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.