Actively Recruiting
Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy
Led by Karl Landsteiner Institute for Lung Research and Pneumological Oncology · Updated on 2025-06-26
70
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
K
Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Lead Sponsor
K
Klinik Pirawarth
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this prospective study is to evaluate the effects of an outpatient pulmonary rehabilitation program on the quality of life, performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy. The main questions it aims to answer are: The primary objective of the study is to assess the effects of outpatient pulmonary rehabilitation (OPR) on exercise capacity measured by difference in the 6-minute walking test (6MWT) in patients with advanced stage lung cancer receiving immunotherapy measured by difference in the 6-minute walking test (6MWT). Secondary endpoints in this study include progression free survival (PFS) and the effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24). Researchers will compare two groups of patients: one group of patients receives 6 weeks of outpatient pulmonary rehabilitation (intervention group), while the other patient group serves as control since this is standard of care to evaluate the effects of outpatient pulmonary rehabilitation.
CONDITIONS
Official Title
Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable and willing to give signed informed consent
- Age 18 years or older at time of screening
- Histological or cytological confirmed non-squamous non-small cell lung cancer
- Previously untreated metastatic (Stage IV) or recurrent NSCLC
- WHO/ECOG performance status of 0 or 1 at enrollment
- At least one lesion qualifying as a RECIST 1.1 target lesion at baseline with recent tumor assessment
- Stable disease, partial or complete response after four cycles of first line chemo-immunotherapy with planned maintenance therapy
- No prior immune-mediated therapy except ongoing first line immunotherapy
You will not qualify if you...
- Physical or cognitive conditions preventing exercise participation
- Symptomatic brain metastases
- Bone metastases with risk of pathological fracture from exercise
- Contraindications for immunotherapy
- More than one primary tumor including mixed histology or synchronous/metachronous tumors
- Evidence of other active cancer
- Medical conditions worsened by exercise including severe heart failure, unstable angina, recent myocardial infarction or cardiac surgery
- Major surgery within 28 days before randomization or planned in next 56 days
- Pregnant or breastfeeding women or patients unwilling to use effective birth control
- Investigator judgment deeming patient unlikely to comply with study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie
Vienna, Austria, 1210
Actively Recruiting
Research Team
O
Oliver Illini, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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