Recruiting
Phase 2

Breathprinting

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07218601

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Breath sample collection

Research blood collection

Study Details

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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07218601

Start date

Oct 10, 2025

Status verified date

Mar, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1 (stage II to IIIB NSCLC)

45 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. Blood sample collections will coincide with the breath collection schedule.

experimental: Cohort 2 (stage I NSCLC)

15 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.

Interventions

Breath sample collection

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

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

Primary outcome measure

  • pathological response (Cohort 1: stages II to IIIB) [ Time Frame: up to 2 years ]
  • progression (Cohort 1: stages II to IIIB) [ Time Frame: up to 2 years ]
  • progression (Cohort 2: Stage I) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Gaetano Rocco, MD

212-639-3478roccog@mskcc.org

David Jones, MD

212-639-6428

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Gaetano Rocco, MD

212-639-3478

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • E-Nose Technology
  • 25-124

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-03-23.