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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Diagnostic Test: Breath sample collection; Diagnostic Test: Research blood collection

Study type: Interventional

Funder types: Other

Identifiers

NCT07218601

25-124

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cohort 1 (stage II to IIIB NSCLC)

Experimental group

Description:

40 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.

Treatment:

Diagnostic Test: Research blood collection

Diagnostic Test: Breath sample collection

Cohort 2 (stage I NSCLC)

Experimental group

Description:

10 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.

Treatment:

Diagnostic Test: Breath sample collection