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

Korábbi kezelés

• Contraindication for immunotherapy
• 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

Más betegség

• Physical or cognitive condition or symptoms that contraindicate execution of physical exercise or participation in a clinical exercise-based trial
• Evidence of other active cancer disease

Egyéb

• Symptomatic brain metastases
• Bone metastases with risk of pathological fracture with exercise training as assessed by treating physician
• 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
• 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

• 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