Using E-Nose Technology to Track Treatment Response in People With Non-Small Cell Lung Cancer

Not Applicable

Recruiting

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT07218601
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure changes in certain chemicals in the breath before and after standard neoadjuvant therapy in people with NSCLC.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-10
• Study First Submitted: 2025-10-16
• Study First Submitted QC: 2025-10-16
• Last Update Submitted: 2025-10-16
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥18
• Untreated clinical stage I NSCLC amenable to upfront surgery
• Untreated stage II to IIIB NSCLC amenable to neoadjuvant treatment followed by surgery
• ECOG Performance Status of ≤2 Of note, the E-nose is a completely noninvasive technology (only breath samples are collected). Therefore, this intervention would have no effects on a developing human fetus. There are therefore no requirements for the study population related to contraception or pregnancy testing.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
pathological response (Cohort 1: stages II to IIIB)	up to 2 years	obtained using E-nose technology, all patients who have pre- and at least one post-neoadjuvant treatment E-nose testing performed will be considered evaluable for the primary endpoint of Major Pathologic Response (MPR). Patients with MPR confirmed on pathologic analysis will be considered to have had an MPR, whereas all other evaluable patients will be considered to have not had an MPR, in accordance with the intention-to-treat analysis.
progression (Cohort 1: stages II to IIIB)	up to 2 years	Differences in VOC expression between time-point assessments will be calculated in terms of VOC percentage change from baseline to assess the magnitude of change among patients with and without progression, particularly at earlier time points. Here, progression is considered as a binary endpoint, where progression includes recurrence, disease progression, or death within 2 years.
progression (Cohort 2: Stage I)	up to 2 years	Differences in VOC expression between time-point assessments will be calculated in terms of VOC percentage change from baseline to assess the magnitude of change among patients with and without progression, particularly at earlier time points. Here, progression is considered as a binary endpoint, where progression includes recurrence, disease progression, or death within 2 years.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States