Lung Non-Small Cell CarcinomaNCT04913311
Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer
An observational study of Lung Non-Small Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Non-Small Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Bronchoscopy with Bronchoalveolar Lavage and Chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 2 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly-diagnosed NSCLC (with a particular focus on lung inflammation) scheduled to undergo chemoradiation followed by immunotherapy.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Ajay Sheshadri, MD, 713-792-6238, asheshadri@mdanderson.org
Ajay Sheshadri
About this study
Official title: Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
- Conditions
- Lung Non-Small Cell Carcinoma
- Being tested
- Biospecimen Collection, Bronchoscopy with Bronchoalveolar Lavage, Chemoradiotherapy, Computed Tomography, Diagnostic Laboratory Biomarker Analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
Bronchoscopy with Bronchoalveolar LavageProcedure or surgery
Also called bronchial washing, Bronchoscopy/Lavage
Undergo bronchoscopy with BAL
ChemoradiotherapyOther
Also called Chemoradiation, CRT, CRTx, Radiochemotherapy
Undergo concurrent chemoradiation per standard of care
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo computed tomography scan
Diagnostic Laboratory Biomarker AnalysisOther
Correlative studies
Immune Checkpoint InhibitorDrug
Receive CPI per standard of care
Nasal Wash and CollectionProcedure or surgery
Also called Nasal Lavage, Nasal Wash, Nasopharyngeal Lavage, Nasopharyngeal Wash
Undergo nasal wash
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
SpirometryProcedure or surgery
Under lung spirometry tests
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Chemoradiotherapy; Procedure: Computed Tomography; Other: Diagnostic Laboratory Biomarker Analysis; Drug: Immune Checkpoint Inhibitor; Procedure: Nasal Wash and Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
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.
Measured: Up to 12 months
Secondary outcomes (6)
The M.D. Anderson Symptom Index (MDASI)
Monitor home spirometry and symptoms to identify early pneumonitis. The MDASI is a brief (less than 5 minutes), psychometrically validated, multi-symptom assessment tool developed for use with cancer patients who are either undergoing or have completed cancer therapies. MDASI-immunotherapy will be administered weekly for the first 9 weeks of study, every two weeks from week 10 to week 54, and monthly until the end of study (week 62). If MDASI increases by 1, patients will be contacted to be evaluated for the possible development of pneumonitis, infection, or disease progression.
Measured: Up to 12 months
Use of home spirometry
Home spirometry will measured forced lung function values such as vital capacity which will be monitored over time in study participants.
Measured: Up to 12 months
Development of treatment-emergent immune related adverse events (irAE)
The development of treatment-emergent irAE overall and separately by type of AE will be summarized by the method of Kaplan and Meier. For AEs with enough events, may use Cox regression models to model the association with covariates of interest, including blood biomarkers.
Measured: Up to 12 months
Sleep quality
Will assess the association between chemotherapy followed by immunotherapy and sleep quality by using the Pittsburgh Quality Sleep Index (PQSI).
Measured: Up to 12 months
Financial hardship
Will assess the association between financial hardship as measured by changes in the Economic Strain and Resilience in Cancer survey and covariates of interest using linear regression.
Measured: Up to 12 months
Dysbiosis
Will be defined as an abnormal microbiome either measured orally or from the gut bacteria in the stool.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start21 Jan 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Sheshadri, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913311
- Sponsor's protocol ID
- 2020-0889
- Other IDs
- NCI-2021-01136, 2020-0889
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy
- ClinicalTrials.gov ID
- NCT04913311
- Acronym / sponsor ID
- 2020-0889
- Conditions
- Lung Non-Small Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection, standard treatment) | – | Procedure: Biospecimen Collection, Procedure: Bronchoscopy with Bronchoalveolar Lavage, Other: Chemoradiotherapy, Procedure: Computed Tomography, Other: Diagnostic Laboratory Biomarker Analysis, Drug: Immune Checkpoint Inhibitor, Procedure: Nasal Wash and Collection, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: SpirometryPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly-diagnosed NSCLC (with a particular focus on lung inflammation) scheduled to undergo chemoradiation followed by immunotherapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood, saliva, stool, and bronchoalveolar lavage samples | Procedure or surgery | Observational (biospecimen collection, standard treatment) |
| Bronchoscopy with Bronchoalveolar LavageAlso: bronchial washing, Bronchoscopy/LavageUndergo bronchoscopy with BAL | Procedure or surgery | Observational (biospecimen collection, standard treatment) |
| ChemoradiotherapyAlso: Chemoradiation, CRT, CRTx, RadiochemotherapyUndergo concurrent chemoradiation per standard of care | Other | Observational (biospecimen collection, standard treatment) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo computed tomography scan | Procedure or surgery | Observational (biospecimen collection, standard treatment) |
| Diagnostic Laboratory Biomarker AnalysisCorrelative studies | Other | Observational (biospecimen collection, standard treatment) |
| Immune Checkpoint InhibitorReceive CPI per standard of care | Drug | Observational (biospecimen collection, standard treatment) |
| Nasal Wash and CollectionAlso: Nasal Lavage, Nasal Wash, Nasopharyngeal Lavage, Nasopharyngeal WashUndergo nasal wash | Procedure or surgery | Observational (biospecimen collection, standard treatment) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (biospecimen collection, standard treatment) |
| Questionnaire AdministrationAncillary studies | Other | Observational (biospecimen collection, standard treatment) |
| SpirometryUnder lung spirometry tests | Procedure or surgery | Observational (biospecimen collection, standard treatment) |
Primary outcome
Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
Time frame: 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.
6 secondary outcomes
The M.D. Anderson Symptom Index (MDASI)
Time frame: Up to 12 months
Use of home spirometry
Time frame: Up to 12 months
Development of treatment-emergent immune related adverse events (irAE)
Time frame: Up to 12 months
Sleep quality
Time frame: Up to 12 months
Financial hardship
Time frame: Up to 12 months
Dysbiosis
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ajay Sheshadri principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Non-Small Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.