Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06436625
Other study ID # OPAL Version 1.1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date August 2026

Study information

Verified date May 2024
Source Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Contact Oliver Illini, Dr.
Phone + 43 1 27700 72227
Email oliver.illini@gesundheitsverbund.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The effect of an outpatient pulmonary rehabilitation program on the quality of life, performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy will be investigated. Comparable data on rehabilitation under ongoing immunotherapy are almost non-existent in a prospective setting. In addition, all patients with metastatic lung cancer could benefit from the study results if the benefit of outpatient rehabilitation can be proven in this patient population. Patients will be randomized into two treatment arms and will be allocated due to randomization process. Both arms will receive standard-of care oncologic therapy according to national and international guidelines. In addition, one arm will receive 6 weeks of a standardized OPR (intervention group). Patients who were randomized into the intervention group will be referred to one of the rehabilitation centers (Therme Wien Med or Klinik Pirawarth in Vienna) regarding of patients choice. The OPR is performed identical at both rehabilitation centers and according to Austrian guidelines (consistency was reassured by both heads of institutes). Before the intervention (T0-baseline, week 0) patients will perform a 6-minute walking test (6MWT) (primary endpoint) together with additional secondary objective measurements (see section secondary endpoints or graphical overview). A follow-up will be performed after completion of OPR (T1, week 6) and every 9 weeks thereafter for the first 52 weeks (T1, FUP-T2, FUP-T3, FUP-T4-T6). After 52 weeks (FUP-T≥7) the intervals for follow-up visits is determined by the treating physician. The end of study is reached if patient shows tumor progression (according to RECIST 1.1 criteria) after FUP-T3 (week 24) or - if patients has experienced tumor progression before FUP-T3 - after FUP-T3 (week 24).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Karl Landsteiner Institute for Lung Research and Pneumological Oncology Klinik Pirawarth, Therme Wien Med

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Progression-free survival (PFS) Progression-free survival is defined as the time from therapy until the date of progressive disease using RECIST 1.1 assessments, or date of death due to any cause, whichever occurs first. 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
Secondary Six Minute Walking Test (longterm) Effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24) Measured at week 15 and 24
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05543330 - A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC Phase 1/Phase 2
Recruiting NCT04106180 - SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC Phase 2
Recruiting NCT05215548 - Primary Tumor Resection With EGFR TKI for Stage IV NSCLC Phase 2
Recruiting NCT04042558 - A Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/-Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies Phase 2
Completed NCT04507217 - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC Phase 2
Recruiting NCT04467801 - Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy Phase 2
Active, not recruiting NCT04027647 - Phase 2 Study of Dacomitinib in NSCLC Phase 2
Recruiting NCT04768491 - Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC
Not yet recruiting NCT04492969 - Prospective Observation of Failure Patterns in NSCLC Treated With ICIs
Recruiting NCT04116918 - Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
Terminated NCT03411473 - Study of AGEN1884 With Pembrolizumab in 1L NSCLC Phase 2
Recruiting NCT03564197 - 18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC N/A
Not yet recruiting NCT06219317 - Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC Phase 2
Not yet recruiting NCT04604470 - Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2
Recruiting NCT05132218 - Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Not yet recruiting NCT04136535 - Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC Phase 2
Completed NCT03184571 - Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Phase 2
Completed NCT06339554 - Alectinib-induced Endocrine Toxicity
Active, not recruiting NCT04549428 - Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced Oligoprogressive NSCLC Phase 2
Recruiting NCT03647956 - Atezolizumab in Combination With Bevacizumab, Carboplatin and Pemetrexed for EGFR-mutant Metastatic NSCLC Patients After Failure of EGFR Tyrosine Kinase Inhibitors Phase 2