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OncoMatch/Clinical Trials/NCT06693336

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

Is NCT06693336 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SMS001 for carcinoma, non-small-cell lung cancer (nsclc).

Phase 2RecruitingToLymph Inc.NCT06693336Data as of May 2026

Treatment: SMS001This 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage IB, IIA, IIB, IIIA (N2) (AJCC 8th edition)

Stage Ib, IIa, IIb or IIIa (N2) for both dose escalation and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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 (176.8 μmol/L); eGFR >60 mL/min/1.73m²; normal renal function

Liver function

AST and ALT < 2.5 x ULN; total bilirubin < 1.5 x ULN; normal liver function

Cardiac function

QTcF: males < 450 msec, females < 470 msec

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; QT interval corrected for heart rate using Frederica's formula (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 →

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