Symptomatic Pneumonitis With Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC.
Johan F Vansteenkiste, Jarushka Naidoo, Corinne Faivre-Finn...
https://pubmed.ncbi.nlm.nih.gov/38455595/Actively Recruiting
Led by The Cooper Health System · Updated on 2026-04-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether using an incentive spirometer can reduce lung complications in people with advanced non-small-cell lung cancer who are receiving chemotherapy and radiation therapy together. The study aims to find out if this device lowers the chances of lung inflammation called pneumonitis and if it improves overall survival and quality of life. This pilot study focuses on patients eligible for combined chemo and radiation treatment with immunotherapy maintenance. Participants will use an incentive spirometer, a device that encourages deep breathing, by taking 10 breaths every hour while awake. They will start using the device as soon as they join the study and continue daily through their chemoradiation treatment phase about 6 to 8 weeks and for up to three months after treatment ends. The study involves one group receiving this intervention alongside their standard cancer care. During the study, participants will complete quality of life questionnaires and undergo pulmonary function tests at the start and at 3, 6, and 12 months after treatment. Researchers will monitor adherence to the spirometry routine through patient logs and check-ins. The main outcome measured is the incidence of pneumonitis over 12 months, along with the severity of pneumonitis and overall survival. The total participation time is approximately one year, including follow-up assessments.
CONDITIONS
Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
V
Veli Bakalov, MD
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The Cooper Health System
Lead Sponsor
The Cooper Foundation
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Incentive Spirometry with Chemo, Radiation, and Immunotherapy | Chemo, Radiation, and Immunotherapy Alone |
|---|---|---|
| What is it? | Incentive spirometry performed multiple times daily, started before and continuing during and after chemo/radiation and immunotherapy, as an add-on to standard lung cancer therapy. | Standard therapy with chemotherapy, radiation, and ongoing immunotherapy, without routine incentive spirometry. |
| Role in study | All trial participants are asked to use incentive spirometry in addition to their prescribed cancer treatments. | Patients receive chemotherapy, radiation, and immunotherapy per clinical guidelines. |
| Primary use | Intended to reduce the risk or severity of treatment-related pneumonitis during and after cancer therapy. | Delivers maximal anti-tumor therapy with the goal of disease control and improved survival in eligible patients. |
| How is it given or performed? | Participants use an incentive spirometer for 10 breaths every hour during waking hours from enrollment, through treatment, and up to three months afterward. | Chemotherapy and radiation are administered per current clinical protocols. Immunotherapy maintenance follows standard schedules. |
| Evidence status | Ongoing clinical investigation; results for this trial are not yet established. | Current standard therapy is supported by multiple published trials and is widely accepted as the optimal care regimen for eligible patients. |
| Important limitations | Limited evidence exists for incentive spirometry as an adjunct in lung cancer patients outside of the trial; unknown adherence and durability of effect. | Despite improvements, pneumonitis and lung injury remain documented complications of combined modality therapy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 weeks
Participants use an incentive spirometer to encourage deep breathing and lung expansion, starting as soon as they enroll. This is done in addition to standard chemotherapy, radiation therapy, and immunotherapy maintenance.
Daily use of the spirometer 10 times every hour while awake during concurrent chemoradiation
Duration - Up to 3 months post-treatment
Participants continue using the incentive spirometer daily after chemoradiation treatment to support respiratory function.
Daily use of the spirometer 10 times every hour while awake
Duration - Up to 12 months post-treatment
Participants complete quality of life assessments and pulmonary function tests to monitor outcomes after treatment and spirometry use.
Assessments at 3, 6, and 12 months post-treatment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Johan F Vansteenkiste, Jarushka Naidoo, Corinne Faivre-Finn...
https://pubmed.ncbi.nlm.nih.gov/38455595/Linda Zhong, Mehmet Altan, Vickie R Shannon...
https://pubmed.ncbi.nlm.nih.gov/32301020/The Cooper Health System
Lead Sponsor
The Cooper Foundation
Collaborating Sponsor