Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy

Recruiting now · Not applicable

Conditions studied: NSCLC Stage IV

In brief

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.

Key facts

Study ID: NCT06436625
Run by: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
People needed: 70
Starts: 2025-01-27
Expected to finish: 2028-01-01
Last updated by the study team: 2025-06-26

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Capable and willing to give signed informed consent, which includes compliance with the requirements
Age ≥ 18 years at the time of screening
Histological or cytological confirmed non-squamous non-small cell lung cancer
Previously untreated patients with histologically or cytologically documented metastatic (Stage IV according to Version 9 on the IASLC Staging Manual in Thoracic oncology) or recurrent NSCLC
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by CT or MRI scan must be performed within 28 days prior to randomization.
Stable disease (SD), partial response (PR) or complete response (CR) (according to RECIST 1.1) after four cycles of first line chemo-immunotherapy and planned maintenance therapy
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies in advanced or metastatic therapy setting except ongoing first line immunotherapy

You may not qualify if…

Physical or cognitive condition or symptoms that contraindicate execution of physical exercise or participation in a clinical exercise-based trial
Symptomatic brain metastases
Bone metastases with risk of pathological fracture with exercise training as assessed by treating physician
Contraindication for immunotherapy
Existence of more than one primary tumor such as: mixed small cell and NSCLC histology; synchronous or metachronous tumors that could represent distinct primary tumors
Evidence of other active cancer disease
Any medical condition that might be worsened by exercise training including, but not restricted to severe congestive heart failure (NYHA III/IV), unstable angina pectoris, myocardial infarction or cardiac surgery 6 months prior to randomization
Major surgical procedure (as defined by the investigator) within 28 days prior to randomization or planned during the next 56 days
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements

Where it is running

Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie — Vienna, Austria (enrolling)

Full record on ClinicalTrials.gov

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