Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07218601

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breath sample collection

Diagnostic Test

Cohort 1: patients undergoing neoadjuvant treatment (stages II to IIIB) will undergo breath sampling (1) at baseline before any treatment, (2) 2 weeks after neoadjuvant therapy, (3) 2 weeks after surgery, (4) 6 months after surgery, and (5) every 6 months for the first 2 years.

Cohort 2: patients who are planned to undergo upfront surgery will undergo breath sampling (1) at baseline before upfront surgery, (2) 2 weeks after surgery, (3) 6 months after surgery, and (4) every 6 months for the first 2 years.

Research blood collection

Diagnostic Test

Cohort 1: Blood sample collections will coincide with the breath collection schedule.

Primary outcomes

  1. pathological response (Cohort 1: stages II to IIIB)

    Time frame: up to 2 years

    obtained using E-nose technology, all patients who have pre-neoadjuvant treatment E-nose testing, pre-surgery E-nose testing, 2 week post-surgery E-nose testing, and E-nose testing every 6 months for 2 years 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.

  2. progression (Cohort 1: stages II to IIIB)

    Time frame: 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.

  3. progression (Cohort 2: Stage I)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Jones, MD

CONTACT

212-639-6428

Gaetano Rocco, MD

CONTACT

[email protected]

212-639-3478

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Electronic Nose (E-nose) Technology to Assess Pathologic Response and Post- Treatment Progression for Non-small Cell Lung Cancer: a Phase II Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.