NSCLC Stage IVOPALNCT06436625
Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy
A study testing outpatient pulmonary rehabilitation in people with NSCLC Stage IV, run by Karl Landsteiner Institute for Lung Research and Pneumological Oncology at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- NSCLC Stage IV
- What is being tested?
- outpatient pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 27 Jan 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie
Vienna, 1210
Oliver Illini, Dr., +43 1 27700 72227, oliver.illini@gesundheitsverbund.at
About this study
Official title: Outpatient Pulmonary Rehabilitation in Patients With Advanced Stage Non-small Cell Lung Cancer Receiving Immunotherapy: a Randomized Controlled Trial (OPAL-study)
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:
Read more
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.
Read the detailed 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).
- Conditions
- NSCLC Stage IV
- Being tested
- outpatient pulmonary rehabilitation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient pulmonary rehabilitationOther
Patients undergo six weeks of an outpatient rehabilitation program in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: outpatient pulmonary rehabilitation |
| Control | No intervention | The control group receives no pulmonary rehabilitation since this is standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and 8 weeks afterwards
Secondary outcomes (2)
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.
Measured: 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)
Effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24)
Measured: Measured at week 15 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start27 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Pirawarth, Therme Wien Med
- Responsible party
- Sponsor
- Investigators
- Oliver Illini, Dr., Principal investigator, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436625
- Sponsor's protocol ID
- OPAL Version 3.0
- Acronym
- OPAL
- Status last verified
- Jun 2025
- First submitted
- 17 May 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Pulmonary Rehabilitation in Patients With Advanced Stage Non-small Cell Lung Cancer Receiving Immunotherapy: a Randomized Controlled Trial (OPAL-study)
- ClinicalTrials.gov ID
- NCT06436625
- Acronym / sponsor ID
- OPAL / OPAL Version 3.0
- Conditions
- NSCLC Stage IV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological OncologyUniversity, hospital or other
- Collaborators
- Klinik Pirawarth, Therme Wien Med
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Pulmonary Rehabilitation | Active comparator | Other: outpatient pulmonary rehabilitationThe intervention group will receive 6 weeks of outpatient pulmonary rehabilitation in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien). |
| Control | No intervention | –The control group receives no pulmonary rehabilitation since this is standard of care. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outpatient pulmonary rehabilitationPatients undergo six weeks of an outpatient rehabilitation program in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien). | Other | Outpatient Pulmonary Rehabilitation |
Primary outcome
Six Minute Walking Test
Time frame: Measured at baseline and 8 weeks afterwards
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.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 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)
Time frame: Measured at week 15 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Illini, Dr. principal investigator
Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient pulmonary rehabilitation in people with NSCLC Stage IV, run by Karl Landsteiner Institute for Lung Research and Pneumological Oncology at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Illini, Dr. (+ 43 1 27700 72227, oliver.illini@gesundheitsverbund.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walking Test (time frame: Measured at baseline and 8 weeks afterwards). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.