Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)Phase 2NCT06693336
An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
A Phase 2 study testing SMS001 in people with Carcinoma, Non-Small-Cell Lung Cancer (NSCLC), run by ToLymph Inc. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
- What is being tested?
- SMS001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Nov 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Pierson Karlyn, 877-526-9172, pierson.karlyn@mayo.edu
Janani S Reisenauer, MD
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Kazuhiro Yasufuku / Principle Investigator, 416-340-4798, kazuhiro.yasufuku@uhn.ca
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of SMS001 in Non-Small Cell Lung Cancer (NSCLC) patients undergoing cancer surgery.
SECONDARY OBJECTIVES:
- To evaluate tumor recurrence at 12-month follow-up in NSCLC lung cancer patients treated at a predefined dose.
- To evaluate disease free survival (DFS) for patients treated with SMS001 at the end of study.
- Being tested
- SMS001
- Keywords
- NSCLC, Carcinoma
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS001Drug
Also called Paclitaxel
One time administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Confirmation | Experimental | All participants will receive a one-time administration of SMS001 undergoing their scheduled lung cancer surgery. Participants are given SMS001 and are watched very closely for side effects. If the side effects are manageable, then more participants are asked to join the study and are given a higher dose of SMS001, until a pre-defined suitable dose is reached. Receives: Drug: SMS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Measured: Day 1 to 52 weeks
Secondary outcomes (1)
Incidence of local tumour recurrence
Time from SMS001 treatment to any clinically, histologically or radiologically confirmed local recurrence of NSCLC to mediastinal lymph nodes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start18 Nov 2024
- Primary completion18 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ToLymph Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto, Mayo Clinic, Rochester, MN
- Responsible party
- Sponsor
- Investigators
- Kazuhiro Yasufuku MD, PhD, FRCSC, Principal investigator, University Health Network, TorontoJanani S Reisenauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693336
- Sponsor's protocol ID
- 132551-1
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06693336
- Acronym / sponsor ID
- 132551-1
- Keywords
- NSCLC, Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- ToLymph Inc.Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto, Mayo Clinic, Rochester, MN
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of SMS001 in Non-Small Cell Lung Cancer (NSCLC) patients undergoing cancer surgery.
SECONDARY OBJECTIVES:
- To evaluate tumor recurrence at 12-month follow-up in NSCLC lung cancer patients treated at a predefined dose.
- To evaluate disease free survival (DFS) for patients treated with SMS001 at the end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Confirmation | Experimental | Drug: SMS001All participants will receive a one-time administration of SMS001 undergoing their scheduled lung cancer surgery. Participants are given SMS001 and are watched very closely for side effects. If the side effects are manageable, then more participants are asked to join the study and are given a higher dose of SMS001, until a pre-defined suitable dose is reached. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS001Also: PaclitaxelOne time administration | Drug | Dose Escalation and Confirmation |
Primary outcome
Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability)
Time frame: Day 1 to 52 weeks
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
1 secondary outcome
Incidence of local tumour recurrence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kazuhiro Yasufuku MD, PhD, FRCSC principal investigator
University Health Network, Toronto
Janani S Reisenauer, MD principal investigator
Mayo Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMS001 in people with Carcinoma, Non-Small-Cell Lung Cancer (NSCLC), run by ToLymph Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Lister / Clinical Research Coordinator / UHN (1-416-340-4857, jennifer.lister@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability) (time frame: Day 1 to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.