OncoMatch/Clinical Trials/NCT06693336
An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer
Official title: 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
Is NCT06693336 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies SMS001 for carcinoma, non-small-cell lung cancer (nsclc).
Treatment: SMS001 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IA, IB, IIA, IIB, IIIA (N2) (other)
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)
Demographics
Prior therapy
Cannot have received: chemotherapy
No prior chemotherapy and/or thoracic radiation therapy
Cannot have received: thoracic radiation therapy
No prior chemotherapy and/or thoracic radiation therapy
Cannot have received: induction (neo-adjuvant) chemotherapy
Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery
Cannot have received: induction (neo-adjuvant) radiation therapy
Patients receiving induction (neo-adjuvant) chemotherapy and/or radiation prior to surgery
Lab requirements
Blood counts
WBC > 2500/mm3; Neutrophil >1500/mm3; Hemoglobin >10 g/dL; Platelet >100,000/ mm3; Normal PT/INR and PTT
Kidney function
Creatinine < 2 mg/dL (equivalent to 176.8 μmol/L); eGFR >60mL/min/1.73m²; Normal renal function at study entry
Liver function
AST and ALT < 2.5 x ULN; Total bilirubin < 1.5 x ULN; Normal liver function at study entry
Cardiac function
QTcF: males < 450msec and females < 470msec
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; eGFR >60mL/min/1.73m²; QTcF: males < 450msec and females < 470msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06693336 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage IA or IB or IIA or IIB or IIIA (N2) is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages