Testing SMS001 for carcinoma, non-small-cell lung cancer (NSCLC)
Official title: 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 Ib-IIIa (N2) Non-Small Cell Lung Cancer (NSCLC) Patients
Interventions
SMS001
One time administration
Canadian Sites (1)
Toronto General Hospital
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +eGFR \>60mL/min/1.73m²
- +Histopathological confirmed NSCLC
- +Stage Ib, IIa, IIb or IIIa (N2) for both dose escalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)
- +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
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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.
- +Age ≥18 years and suitable for lung cancer surgery
- +No prior chemotherapy and/or thoracic radiation therapy
Exclusion
- −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.
- −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.
- −Unwilling or unable to follow protocolProtocolThe detailed plan a study must follow.Read more → requirements.
- −Any other condition (e.g., psychiatric disorder) that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may interfere with the patient's ability to comply with the study requirements or visit schedule.
- −Pregnant or nursing female subjects.
- −Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: SMS001.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 42 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Day 1 to 52 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Evaluate the incidence of treatment-emergent adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (Safety and Tolerability) — measured over Day 1 to 52 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06693336 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SMS001Drug
One time administration
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Day 1 to 52 weeks.
The study as a whole is currently expected to finish around 2026-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 42 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; Rochester, Minnesota, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (1)
Mayo Clinic
Rochester, Minnesota, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.