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New chemo formula aims to keep lung cancer away after surgery

NCT ID NCT06693336

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests a drug called SMS001, a new version of the chemotherapy paclitaxel, in 42 people with non-small cell lung cancer (stages Ib to IIIa). The goal is to see if a single dose after surgery can safely prevent the cancer from coming back. Researchers will monitor side effects and check for tumor recurrence in the chest.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SMS001 (a form of the chemotherapy drug paclitaxel)
What this could lead to
If it works, this could help prevent lung cancer from coming back after surgery, giving patients more time without recurrence.
What could go wrong
This is an early Phase IIa trial with only 42 participants, so results may not apply to everyone. The drug is a chemotherapy agent, which can cause side effects like low blood counts and nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

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