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/38455595Actively Recruiting
Led by The Cooper Health System · Updated on 2026-04-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
T
The Cooper Health System
Lead Sponsor
T
The Cooper Foundation
Collaborating Sponsor
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
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
Total: 1 location
1
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States, 08103
Actively Recruiting
V
Veli Bakalov, MD
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/38455595Linda Zhong, Mehmet Altan, Vickie R Shannon...
https://pubmed.ncbi.nlm.nih.gov/32301020