Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer
- Conditions
- Lung Non-Small Cell Carcinoma
- Registration Number
- NCT04913311
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria:<br><br> - Newly-diagnosed NSCLC patients who will be undergoing concurrent chemotherapy and<br> radiotherapy (XRT) followed by immune checkpoint inhibitors (CPI) therapy with<br> durvalumab, as per the PACIFIC trial<br><br> - Willing to undergo all treatment and evaluation at MD Anderson Cancer Center (MDACC)<br><br> - Has access to a smartphone with the ability to transmit data via wireless connection<br> or through their personal cellular plan<br><br> - Able and willing to perform home spirometry (HS) weekly without absolute<br> contraindications to performing spirometry
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
- Secondary Outcome Measures
Name Time Method The M.D. Anderson Symptom Index (MDASI);Use of home spirometry;Development of treatment-emergent immune related adverse events (irAE);Sleep quality;Financial hardship;Dysbiosis