Recruiting

Chemoradiation & Immunotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04913311

Conditions

Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bronchoscopy with Bronchoalveolar Lavage

Chemoradiotherapy

Computed Tomography

Diagnostic Laboratory Biomarker Analysis

Study Details

Brief summary:

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.

Conditions

Lung Non-Small Cell Carcinoma

Study ID

NCT04913311

Start date

Jan 21, 2021

Status verified date

Aug, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection, standard treatment)

Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.

Interventions

Biospecimen Collection

Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples

Bronchoscopy with Bronchoalveolar Lavage

Undergo bronchoscopy with BAL

Chemoradiotherapy

Undergo concurrent chemoradiation per standard of care

Computed Tomography

Undergo computed tomography scan

Diagnostic Laboratory Biomarker Analysis

Correlative studies

Immune Checkpoint Inhibitor

Receive CPI per standard of care

Nasal Wash and Collection

Undergo nasal wash

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Spirometry

Under lung spirometry tests

Primary outcome measure

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

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ajay Sheshadri, MD

713-792-6238asheshadri@mdanderson.org

Principal Investigator:

Ajay Sheshadri

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-11.