Outpatient pulmonary rehabilitation for lung cancer patients on immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study evaluates the impact of an outpatient pulmonary rehabilitation program on the quality of life, exercise capacity, and tumor growth in patients with Stage IV non-small-cell lung cancer receiving immunotherapy. Patients will be randomized into two groups: one receiving standard oncologic therapy alone and the other receiving the same therapy plus a 6-week outpatient rehabilitation program. The primary outcome will be measured using the 6-minute walking test, with secondary endpoints including progression-free survival and long-term exercise capacity. The study aims to fill a gap in existing data regarding rehabilitation for this patient population.

Why it matters

Who can join: the full rules

Inclusion criteria

* 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

Exclusion criteria

* 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's running

• Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Oliver Illini, Dr. — Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf
• Study coordinator: Oliver Illini, Dr.
• Email: oliver.illini@gesundheitsverbund.at
• Phone: + 43 1 27700 72227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.