NCT07218601

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer

Timeline
16mo left

Started Oct 2025

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Oct 2025Oct 2027

Study Start

First participant enrolled

October 10, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

October 16, 2025

Last Update Submit

March 19, 2026

Conditions

Non-Small Cell Lung Cancer

Keywords

E-Nose Technology25-124

Outcome Measures

Primary Outcomes (3)

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

    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.

    up to 2 years

  • progression (Cohort 1: stages II to IIIB)

    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.

    up to 2 years

  • progression (Cohort 2: Stage I)

    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.

    up to 2 years

Study Arms (2)

Cohort 1 (stage II to IIIB NSCLC)

EXPERIMENTAL

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.

Diagnostic Test: Breath sample collectionDiagnostic Test: Research blood collection

Cohort 2 (stage I NSCLC)

EXPERIMENTAL

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.

Diagnostic Test: Breath sample collection

Interventions

Research blood collectionDIAGNOSTIC_TEST

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

Cohort 1 (stage II to IIIB NSCLC)
Breath sample collectionDIAGNOSTIC_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.

Cohort 1 (stage II to IIIB NSCLC)Cohort 2 (stage I NSCLC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gaetano Rocco, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Rocco, MD

CONTACT

212-639-3478roccog@mskcc.org

David Jones, MD

CONTACT

212-639-6428

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2025

First Posted

October 20, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)