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

Conditions

• Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• SMS001 — DRUG
  One time administration

Study Details

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.

Key Dates

Start date

Nov 18, 2024

Status verified

Mar 2026

Primary completion

Nov 18, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation and Confirmation
  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.

Primary Outcome Measure

Evaluate the incidence of treatment-emergent adverse events (Safety and Tolerability) [ Time Frame: Day 1 to 52 weeks ]

Central Contacts

• Jennifer Lister / Clinical Research Coordinator / UHN
  1-416-340-4857
  [email protected]

Locations (1)

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