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

Phase 2RecruitingNCT07218601

Memorial Sloan Kettering Cancer Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

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.

Research blood collectionDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 2 years

progression (Cohort 2: Stage I)

Time frame: up to 2 years

Central Contacts

Gaetano Rocco, MD

CONTACT

212-639-3478 roccog@mskcc.org

David Jones, MD

CONTACT

212-639-6428

Data from ClinicalTrials.gov

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