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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 (Jun 2026). This Phase 2 trial studies SMS001 for carcinoma, non-small-cell lung cancer (nsclc).

Phase 2RecruitingToLymph Inc.NCT06693336Data as of Jun 2026Location: United States · Canada

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

Treatments studied

Other

SMS001

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)

Demographics

Ages ≤ 80

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 →

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 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.

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