Lung Non-Small Cell CarcinomaNCT06983899
Exercise Training for the Improvement of Immune Activity and Treatment Outcomes During Immunotherapy for Non-small Cell Lung Cancer, BOOST Trial
A study testing Aerobic Exercise, Exercise Intervention and Educational Intervention in people with Lung Non-Small Cell Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma
- What is being tested?
- Aerobic Exercise, Exercise Intervention and Educational Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histologically diagnosed with NSCLC.
- Currently receiving immunotherapy with a minimum of one month of treatment completed.
- Having a plan to continue immunotherapy for at least 24 weeks (i.e., study intervention period) at the time of recruitment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.
- Able to understand and willingness to provide study consent.
Who cannot join
- Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.
- Having medical conditions clinically unstable or uncontrollable, with medications that are deemed high-risk for exercise participation by the study team in consultation with the treating oncologist, using the electric medical record (EMR) and Physical Activity Readiness Questionnaire (PAR-Q). This includes but is not limited to: recent (< 6 months) myocardial infarction, uncontrolled arrhythmias, decompensated heart failure, unstable angina, symptomatic severe aortic stenosis, uncontrolled hypertension (≥ 180/110 mmHg), uncontrolled diabetes (hemoglobin A1c [HbA1c] > 10% with symptoms), severe chronic obstructive pulmonary disease requiring hospitalization in past 3 months, and bone metastases with imminent fracture risk. These exclusions are based on the American College of Sports Medicine (ACSM)'s Guidelines for Exercise Testing and Prescription and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR)'s Guidelines for Cardiac Rehabilitation Programs for safe exercise in clinical populations.
- Having a high risk for noncompliance with study procedures, including but not limited to: informed consent, participation in outcome assessments, completion of fasting blood draws, attendance at scheduled sessions, adherence to supervised virtual exercise sessions, and appropriate use of provided monitoring equipment (e.g., heart rate monitor, blood pressure monitor, SpO2 monitor). This determination will be based on a composite assessment of the following factors: history of missed oncology appointments (i.e., three or more uninformed no-shows in the prior six months) and poor responsiveness to study communications (i.e., three or more repeated unreturned calls or emails during the recruitment stage). We will also consider any demonstrated difficulty following instructions during initial scheduling or onboarding, or clinical concern raised by the referring provider. Participants meeting one or more of these criteria likely to impair participation will be considered ineligible.
- Patients who are non-English speaking that would prevent their participation in the participant survey.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Dong-Woo Kang, PhD, 206-667-5188, dkang@fredhutch.org
Dong-Woo Kang, PhD
About this study
Official title: Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial
This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. The use of immunotherapy for the treatment of NSCLC has been rapidly increasing. Although immunotherapy have shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to it can occur. This could be due to poor immune activity. It has been shown that exercise can enhance systemic immune activity in various ways. The exercise training used in this study is aerobic interval training. Aerobic interval training increases the heart rate and the body's use of oxygen and alternates short periods of intense aerobic exercise with less intense recovery periods. This may cause biological changes which may improve immune activity and treatment response in patients with NSCLC who are receiving immunotherapy.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes once a week (QW) during weeks 1-4, twice a week (BIW) during weeks 5-8, and three times a week (TIW) during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, heart rate (HR) monitor, blood pressure (BP) monitor, oxygen saturation (SPO2) monitor, and a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study.
ARM II: Patients receive a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, DEXA, PFT, physical fitness and function tests, and questionnaires throughout the study.
After completion of study intervention, patients are followed up at week 26 and then every 3 months up to the completion of immunotherapy.
- Conditions
- Lung Non-Small Cell Carcinoma
- Being tested
- Aerobic Exercise, Exercise Intervention, Educational Intervention, Dual X-ray Absorptiometry, Electronic Health Record Review
- 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.
Aerobic ExerciseOther
Also called Aerobic Activity
Complete virtual home-based aerobic interval training sessions
Receive stationary bike, HR monitor, BP monitor, SPO2 monitor
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive general healthy lifestyle guidebook
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)
Undergo DEXA
Electronic Health Record ReviewOther
Ancillary studies
Cardiopulmonary Exercise TestingOther
Also called CPET, CPX
Ancillary studies
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood sample collection
Pulmonary Function TestProcedure or surgery
Also called PFT
Undergo PFT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (aerobic training sessions, equipment, guidebook) | Experimental | Patients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes QW during weeks 1-4, BIW during weeks 5-8, and TIW during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, HR monitor, BP monitor, SPO2 monitor, and a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study. Receives: Other: Aerobic Exercise; Other: Exercise Intervention; Other: Educational Intervention; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing; Other: Physical Performance Testing; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Procedure: Pulmonary Function Test |
| Arm II (guidebook) | Active comparator | Patients receive a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study. Receives: Other: Educational Intervention; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing; Other: Physical Performance Testing; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Procedure: Pulmonary Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in neutrophil-to-lymphocyte ratio (NLR)
The primary analysis will follow an intention-to-treat approach, using a two-sample t-test to compare changes in NLR from baseline between the groups.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Secondary outcomes (25)
Mean difference in immune parameters
To analyze changes in immune parameters (e.g., T-cells, natural killer cells, B-cells) a two-sample t-test will compare changes between the groups.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in inflammatory cytokines
To analyze changes in inflammatory cytokines (e.g., IL-6, IL-15) a two-sample t-test will compare changes between the groups.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in fasting glucose (mg/dL)
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in insulin (µIU/mL)
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in lipid profile
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in circulating tumor markers
To analyze changes in tumor markers [e.g., circulating tumor deoxyribonucleic acid (DNA)] a two-sample t-test will compare changes between the groups.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body weight (kg), assessed via weight scale
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body mass index (BMI) (kg/m²), calculated from height and weight
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in lean mass (kg), assessed via DEXA
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body fat percentage (%), assessed via DEXA
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body fat mass (kg), assessed via DEXA
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV (L), assessed via spirometry
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV1 (L), derived from FEV1
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV1/FEV, derived from FEV and FEV1A
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in cardiopulmonary fitness
Will be assessed as peak oxygen consumption (VO2peak) by a graded maximal or submaximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged over set intervals (i.e., 30-second) during the test. VO2peak will be reported in both relative and absolute terms.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in timed balance
Balance will be assessed under 3 conditions: a) side-by-side stand with both feet plated on the ground for 10 seconds or when the subject steps out of position; b) semi-tandem stand with the side of the heel of one foot touching the big toe of the other foot for 10 seconds or when the subject steps out of position; c) tandem stand with the heel of one foot touching the big toe of the other foot for 10 seconds or when the subject steps out of position.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in gait speed
Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in chair stand
Chair stand will be assessed that subjects will perform a single chair stand and if successful, they will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in health-related quality of life
Health-related quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. The scale ranges from 0 to 100, with higher scores on the global health status and functioning scales indicating better quality of life, and higher scores on symptom scales indicating worse symptoms.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in lung cancer-related quality of life
Lung cancer-related quality of life will be assessed at baseline and post-intervention using the EORTC QLQ-Lung Cancer 29 (QLQ-LC29). The scale ranges from 0 to 100, with higher functioning scores indicating better quality of life and higher symptom scores indicating worse symptoms.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in immunotherapy-related symptoms
Immunotherapy-related symptoms will be assessed at baseline, mid-point, post-intervention, and during follow-up using the MD Anderson Symptom Inventory (MDASI) Immunotherapy Early Phase Trials module (EPT). Each symptom is rated from 0 ("not present") to 10 ("as bad as you can imagine"), with higher scores indicating worse symptom severity.
Measured: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Mean difference in symptomatic treatment toxicity
Symptomatic treatment toxicity will be assessed at baseline, mid-point, post-intervention, and during follow-up using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Each item is rated from 0 to 4, with higher scores indicating greater severity, frequency, or interference of adverse events.
Measured: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Mean difference in anxiety and depression
Will be assessed using the Hospital Anxiety and Depression Scale. Each subscale (anxiety and depression) ranges from 0 to 21, with higher scores indicating greater levels of anxiety or depression.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in sleep quality
Will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in exercise behavior
Exercise behavior will be assessed at baseline, mid-point, post-intervention, and during follow-up using the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Weekly exercise scores are calculated, with higher scores indicating greater amounts of physical activity. A minimum value is 0 and maximum value is 10080 minutes per week.
Measured: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start28 Jan 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dong-Woo Kang, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983899
- Sponsor's protocol ID
- RG1125289
- Other IDs
- NCI-2025-02781, 20819, R00CA287050
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2025
- Last updated
- 23 Jun 2026
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial
- ClinicalTrials.gov ID
- NCT06983899
- Acronym / sponsor ID
- RG1125289
- Conditions
- Lung Non-Small Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 21 May 2025 (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.
This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. The use of immunotherapy for the treatment of NSCLC has been rapidly increasing. Although immunotherapy have shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to it can occur. This could be due to poor immune activity. It has been shown that exercise can enhance systemic immune activity in various ways. The exercise training used in this study is aerobic interval training. Aerobic interval training increases the heart rate and the body's use of oxygen and alternates short periods of intense aerobic exercise with less intense recovery periods. This may cause biological changes which may improve immune activity and treatment response in patients with NSCLC who are receiving immunotherapy.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes once a week (QW) during weeks 1-4, twice a week (BIW) during weeks 5-8, and three times a week (TIW) during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, heart rate (HR) monitor, blood pressure (BP) monitor, oxygen saturation (SPO2) monitor, and a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study.
ARM II: Patients receive a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, DEXA, PFT, physical fitness and function tests, and questionnaires throughout the study.
After completion of study intervention, patients are followed up at week 26 and then every 3 months up to the completion of immunotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (aerobic training sessions, equipment, guidebook) | Experimental | Other: Aerobic Exercise, Other: Exercise Intervention, Other: Educational Intervention, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Other: Cardiopulmonary Exercise Testing, Other: Physical Performance Testing, Other: Questionnaire Administration, Procedure: Biospecimen Collection, Procedure: Pulmonary Function TestPatients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes QW during weeks 1-4, BIW during weeks 5-8, and TIW during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, HR monitor, BP monitor, SPO2 monitor, and a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study. |
| Arm II (guidebook) | Active comparator | Other: Educational Intervention, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Other: Cardiopulmonary Exercise Testing, Other: Physical Performance Testing, Other: Questionnaire Administration, Procedure: Biospecimen Collection, Procedure: Pulmonary Function TestPatients receive a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Histologically diagnosed with NSCLC.
- Currently receiving immunotherapy with a minimum of one month of treatment completed.
- Having a plan to continue immunotherapy for at least 24 weeks (i.e., study intervention period) at the time of recruitment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.
Key exclusion criteria (4 listed)
- Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.
- Having medical conditions clinically unstable or uncontrollable, with medications that are deemed high-risk for exercise participation by the study team in consultation with the treating oncologist, using the electric medical record (EMR) and Physical Activity Readiness Questionnaire (PAR-Q). This includes but is not limited to: recent (< 6 months) myocardial infarction, uncontrolled arrhythmias, decompensated heart failure, unstable angina, symptomatic severe aortic stenosis, uncontrolled hypertension (≥ 180/110 mmHg), uncontrolled diabetes (hemoglobin A1c [HbA1c] > 10% with symptoms), severe chronic obstructive pulmonary disease requiring hospitalization in past 3 months, and bone metastases with imminent fracture risk. These exclusions are based on the American College of Sports Medicine (ACSM)'s Guidelines for Exercise Testing and Prescription and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR)'s Guidelines for Cardiac Rehabilitation Programs for safe exercise in clinical populations.
- Having a high risk for noncompliance with study procedures, including but not limited to: informed consent, participation in outcome assessments, completion of fasting blood draws, attendance at scheduled sessions, adherence to supervised virtual exercise sessions, and appropriate use of provided monitoring equipment (e.g., heart rate monitor, blood pressure monitor, SpO2 monitor). This determination will be based on a composite assessment of the following factors: history of missed oncology appointments (i.e., three or more uninformed no-shows in the prior six months) and poor responsiveness to study communications (i.e., three or more repeated unreturned calls or emails during the recruitment stage). We will also consider any demonstrated difficulty following instructions during initial scheduling or onboarding, or clinical concern raised by the referring provider. Participants meeting one or more of these criteria likely to impair participation will be considered ineligible.
- Patients who are non-English speaking that would prevent their participation in the participant survey.
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 |
|---|---|---|
| Aerobic ExerciseAlso: Aerobic ActivityComplete virtual home-based aerobic interval training sessions | Other | Arm I (aerobic training sessions, equipment, guidebook) |
| Exercise InterventionReceive stationary bike, HR monitor, BP monitor, SPO2 monitor | Other | Arm I (aerobic training sessions, equipment, guidebook) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive general healthy lifestyle guidebook | Other | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)Undergo DEXA | Procedure or surgery | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Cardiopulmonary Exercise TestingAlso: CPET, CPXAncillary studies | Other | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo blood sample collection | Procedure or surgery | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
| Pulmonary Function TestAlso: PFTUndergo PFT | Procedure or surgery | Arm I (aerobic training sessions, equipment, guidebook), Arm II (guidebook) |
Primary outcome
Mean difference in neutrophil-to-lymphocyte ratio (NLR)
Time frame: Baseline (Week 1) and post-intervention (Week 26)
The primary analysis will follow an intention-to-treat approach, using a two-sample t-test to compare changes in NLR from baseline between the groups.
25 secondary outcomes
Mean difference in immune parameters
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in inflammatory cytokines
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in fasting glucose (mg/dL)
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in insulin (µIU/mL)
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in lipid profile
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in circulating tumor markers
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body weight (kg), assessed via weight scale
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body mass index (BMI) (kg/m²), calculated from height and weight
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in lean mass (kg), assessed via DEXA
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body fat percentage (%), assessed via DEXA
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body fat mass (kg), assessed via DEXA
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV (L), assessed via spirometry
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV1 (L), derived from FEV1
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV1/FEV, derived from FEV and FEV1A
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in cardiopulmonary fitness
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in timed balance
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in gait speed
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in chair stand
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in health-related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in lung cancer-related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in immunotherapy-related symptoms
Time frame: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Mean difference in symptomatic treatment toxicity
Time frame: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Mean difference in anxiety and depression
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in sleep quality
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in exercise behavior
Time frame: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
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 23 Jun 2026.
- 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.
Dong-Woo Kang, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Exercise Intervention and Educational Intervention in people with Lung Non-Small Cell Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
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 6 inclusion and 4 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 23 Jun 2026. 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 United States. 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 Dong-Woo Kang, PhD (206-667-5188, dkang@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in neutrophil-to-lymphocyte ratio (NLR) (time frame: Baseline (Week 1) and post-intervention (Week 26)). 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 23 Jun 2026.