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

Launched by KARL LANDSTEINER INSTITUTE FOR LUNG RESEARCH AND PNEUMOLOGICAL ONCOLOGY · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the impact of an outpatient pulmonary rehabilitation program on patients with advanced non-small-cell lung cancer (NSCLC) who are receiving immunotherapy. The main goal is to see if this rehabilitation program can help improve patients' exercise ability, specifically looking at how far they can walk in six minutes. Additionally, the study aims to explore how this program affects the patients' overall quality of life and the growth of their tumors over time.

To participate in this trial, patients must be at least 18 years old and have confirmed Stage IV NSCLC that has not been previously treated with immunotherapy. They should also be in relatively good health, with a performance status of 0 or 1, meaning they are fully active or only slightly limited in their daily activities. Participants will be divided into two groups: one will undergo six weeks of rehabilitation, while the other group will continue with standard care. Throughout the study, patients can expect regular assessments to monitor their progress and overall health. This trial is currently recruiting participants and offers an opportunity to potentially improve their exercise capacity and quality of life during treatment.

Gender

ALL

Eligibility criteria

• • 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