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

NCT06436625 | Recruiting

• 1 other identifier: OPAL Version 3.0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

NSCLC Stage IV

Outcome Measures

Primary Outcomes (1)

• Six Minute Walking Test

  The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity and will be measured at baseline and 8 weeks afterwards.

  Measured at baseline and 8 weeks afterwards

Secondary Outcomes (2)

• Progression-free survival (PFS)

  from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Six Minute Walking Test (longterm)

  Measured at week 15 and 24

Study Arms (2)

Outpatient Pulmonary Rehabilitation

ACTIVE COMPARATOR

The intervention group will receive 6 weeks of outpatient pulmonary rehabilitation in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).

Other: outpatient pulmonary rehabilitation

Control

NO INTERVENTION

The control group receives no pulmonary rehabilitation since this is standard of care.

Interventions

outpatient pulmonary rehabilitation OTHER

Patients undergo six weeks of an outpatient rehabilitation program in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).

Outpatient Pulmonary Rehabilitation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Karl Landsteiner Institute for Lung Research and Pneumological Oncology: lead
• Klinik Pirawarth: collaborator
• Therme Wien Med: collaborator

Study Sites (1)

Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie

Vienna, 1210, Austria

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oliver Illini, Dr.

  Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Illini, Dr.

CONTACT

+ 43 1 27700 72227; oliver.illini@gesundheitsverbund.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 31, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)