Identifying biomarkers for lung inflammation after cancer treatment
Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy
This study is trying to find early signs of lung inflammation in people with non-small cell lung cancer after they receive chemoradiotherapy and immunotherapy, to help improve their treatment and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | durvalumab, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04913311 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the side effects of chemoradiotherapy followed by immunotherapy in patients with non-small cell lung cancer, focusing on the occurrence of lung inflammation known as pneumonitis. Researchers will collect blood, stool, and saliva samples, along with lung function data, to create a comprehensive database that correlates treatment with adverse effects. The study aims to identify early signs of lung function problems, potentially leading to quicker interventions and improved patient outcomes. Additionally, it will explore the impact of treatment on sleep quality and gut health.
Who should consider this trial
Good fit: Ideal candidates are newly-diagnosed patients with non-small cell lung cancer who will receive concurrent chemotherapy and radiotherapy followed by immunotherapy.
Not a fit: Patients who are not undergoing the specified treatment regimen or who have contraindications to spirometry may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of lung inflammation in patients undergoing cancer treatment.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for treatment-related adverse events, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly-diagnosed NSCLC patients who will be undergoing concurrent chemotherapy and radiotherapy (XRT) followed by immune checkpoint inhibitors (CPI) therapy with durvalumab, as per the PACIFIC trial * Willing to undergo all treatment and evaluation at MD Anderson Cancer Center (MDACC) * Has access to a smartphone with the ability to transmit data via wireless connection or through their personal cellular plan * Able and willing to perform home spirometry (HS) weekly without absolute contraindications to performing spirometry
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ajay Sheshadri — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.