Back to search results

Predicting Lung Inflammation After Chemoradiotherapy and Immunotherapy for Non-Small Cell Lung Cancer

This study is looking for ways to predict lung inflammation (pneumonitis) in patients with non-small cell lung cancer (NSCLC) who are receiving chemotherapy and radiation (chemoradiotherapy) followed by immunotherapy with durvalumab. Researchers will collect blood, saliva, stool, and lung fluid samples, along with information from CT scans and lung function tests. The goal is to understand how these treatments affect your body and to identify early signs of pneumonitis. This information could help doctors treat side effects sooner and improve care for future patients. The study aims to enroll 150 participants and is currently observational, meaning it watches what happens to patients without assigning specific treatments.

Study design
This is an observational study that plans to enroll 150 participants. It is not specified if it's randomized or blinded.
What's involved
You would undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples. You would also have CT scans and receive standard chemoradiotherapy and durvalumab treatment for up to 62 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, development of pneumonitis, will be measured for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04913311

Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer

Recruiting
Not specifiedAll AgesObservational
M.D. Anderson Cancer Center
~150 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBronchoscopy with Bronchoalveolar LavageChemoradiotherapyComputed TomographyDiagnostic Laboratory Biomarker AnalysisImmune Checkpoint Inhibitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
Measured over Up to 12 months

Conditions

Lung Non-Small Cell Carcinoma

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ajay Sheshadri · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Ajay Sheshadri, MD
[email protected]
713-792-6238
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

What this trial measures

  • Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)Up to 12 months

    All possible pneumonitis events will be adjudicated by an expert committee including Dr. Altan, Dr. Sheshadri, an expert infectious disease doctor, and an expert thoracic radiologist. Logistic regression will be used to assess the association between the development of pneumonitis and covariates of interest. Will also use logistic regression to model the association between the development of immune checkpoint inhibitor (CPI)-related pneumonitis and separately the development of radiation related pneumonitis. Secondary analyses of the primary endpoint will include assessing the time to the development of pneumonitis. Cox regression models will be fit in a similar manner to assess the association with the same covariates.