Health TrialsbyHealthPanel

An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer

ConditionCarcinoma, Non-Small-Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorToLymph Inc.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SMS001

    Drug

    One time administration

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Dose Escalation and ConfirmationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability)

Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

Time frame
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

Time frame
1 year

Other outcomes

1

Disease free survival (DFS)

Time from SMS001 treatment to any confirmed recurrence of NSCLC at the end of the study

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ToLymph Inc.

Lead sponsor

University Health Network, Toronto

Collaborator

Mayo Clinic, Rochester, MN

Collaborator

Source ClinicalTrials.gov
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