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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center

About this trial

This study looks at the side effects of chemotherapy and radiation (chemoradiation) followed by immunotherapy in patients with non-small cell lung cancer, with a particular focus on lung inflammation (pneumonitis). By collecting blood, stool and saliva samples, and data from lung function tests, researchers may be able to create a database of information about treatment and side effects in patients with non-small cell lung cancer who are receiving chemoradiation followed by immunotherapy. The information gained from this study may also help researchers find signs of problems with lung function earlier rather than later, since lung function is checked more often than routine care. This may improve how quickly these issues can be treated, and future patients may benefit from what is learned.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bronchoscopy with Bronchoalveolar Lavage
  • Chemoradiotherapy
  • Computed Tomography
  • Diagnostic Laboratory Biomarker Analysis
  • Immune Checkpoint Inhibitor
  • Nasal Wash and Collection
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Spirometry

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators