Clinical trial NCT04913311: Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer
Official title: Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Non-Small Cell Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly-diagnosed NSCLC (with a particular focus on lung inflammation) scheduled to undergo chemoradiation followed by immunotherapy.

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.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the association between the incidence of concurrent chemoradiation and subsequent immunotherapy-related adverse events, particularly radiation and immune-related pneumonitis, in patients with non-small cell lung cancer (NSCLC), and various clinicopathologic, radiologic, tumor, and demographic covariates of interest.

SECONDARY OBJECTIVES:

I. To correlate clinicopathologic, radiologic data and tumor characteristics with systemic longitudinal assessments of blood biomarkers for toxicity and response to therapy.

II. To monitor home spirometry and symptoms to identify early pneumonitis. III. To collect blood and microbiome samples from patients on immunotherapy and biopsy samples from toxicity sites at the time of toxicity to evaluate predictive markers for therapy related adverse events.

IV. To determine the effect of concurrent chemotherapy followed by immunotherapy on sleep quality.

V. To determine the impact of sleep disturbance on gut and oral dysbiosis. VI. To characterize longitudinal changes in fatigue and financial toxicity with concurrent chemotherapy followed by immunotherapy.

OUTLINE:

Patients undergo collection of blood, stool and saliva samples at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 62 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and samples 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 computed tomography (CT) within 4 weeks, lung function tests including home spirometry three times a week (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 once a week (QW) for weeks 1-9, twice a week (BIW) during weeks 5-54, and once a month until week 62.

Eligibility 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

Primary outcomes:
measure: Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
timeFrame: Up to 12 months
Secondary outcomes:
measure: The M.D. Anderson Symptom Index (MDASI)
timeFrame: Up to 12 months
measure: Use of home spirometry
timeFrame: Up to 12 months
measure: Development of treatment-emergent immune related adverse events (irAE)
timeFrame: Up to 12 months
measure: Sleep quality
timeFrame: Up to 12 months
measure: Financial hardship
timeFrame: Up to 12 months
measure: Dysbiosis
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ajay Sheshadri
role: PRINCIPAL_INVESTIGATOR
References: