Exercise as a Tool to Improve Response to Immunotherapy in Non-small Cell Lung Cancer

NCT07267000 | Not Yet Recruiting DMC

• 2 other identifiers: ImmuEXPAT1625724
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This project is about the effect of a 12-week training therapy intervention in patients suffering from non-small cell lung cancer. It has widely been accepted that exercise is preventive against certain types of cancer. Individuals following an active lifestyle have a significantly lower risk for several chronic diseases, including cancer, as compared to sedentary ones. However, evidence is still lacking for exercise as part of routine cancer treatment (as it has already been implemented routinely in patients with heart disease, for example). In this study, patients suffering from non-small cell lung cancer undergo either a 12-week training program consisting of moderate-intensity continuous exercise (MICE), or a 12-week program with high-intensity interval exercise. Both groups will be compared to a control group receiving standard exercise recommendations. The response to immunotherapy, measured by the radiologic therapy response, will be the main endpoint. Additionally, blood will be taken from the patients at different timepoints, and blood samples will be tested for immunologic changes. FACS analysis will be used to assess the properties of immune cells and potential changes upon the exercise regimen. Mitochondrial function will be assessed via the Seahorse machine, and mass spectrometry (lipidomics) will be used for the analysis of lipid profile changes.

Conditions

Non-Small Cell Lung Cancer; Exercise Training; Immunotherapy

Keywords

Non-small cell lung cancer; Exercise; Immunotherapy; Outcome

Outcome Measures

Primary Outcomes (1)

• Response to immunotherapy

  Response to immunotherapy will be measured on the one hand metrically based on the change of tumor volume in mm3, and on the other hand based on the RECIST criteria.

  From enrollment to the first CT scan after the 12 week training therapy intervention

Secondary Outcomes (4)

• Immunologic changes - FACS analysis

  From enrollment to after completion of the 12 week training therapy intervention

• Seahorse analysis

  From enrollment to after completion of the exercise intervention

• Mass spectrometry - Lipidomics

  From enrollment to after completion of the 12 week exercise intervention.

• Cytokine profiling

  From enrollment to after completion of the 12 week training therapy intervention.

Study Arms (3)

Continuous Exercise

EXPERIMENTAL

Patients in this arm will undergo a 12-week training therapy regimen consisting of twice weekly supervised moderate-intensity continuous exercise (MICE) and home-based walking exercise for 30 minutes, five times a week, in addition.

Behavioral: Exercise

High Intensity Interval Exercise

EXPERIMENTAL

Patients in this arm will undergo a 12-week training therapy regimen consisting of twice weekly supervised high-intensity interval exercise and home-based walking exercise for 30 minutes, five times a week, in addition.

Behavioral: Exercise

Controls

ACTIVE COMPARATOR

Patients in this arm will receive general recommendations on an active lifestyle, but will not take part in supervised training sessions and are not asked to do home-based exercise either.

Other: Control

Interventions

Exercise BEHAVIORAL

1 study arm doing continuous type exercise will be compared to 1 study arm doing high-intensity interval exercise, over the course of 12 weeks, respectively. Both arms will be compared to sedentary control patients.

Also known as: Home-based walking exercise

Continuous Exercise; High Intensity Interval Exercise

Control OTHER

For patients in the control group, general exercise recommendations (e.g. recommendations by the CDC suitable for all adult individuals) will be given, however, no training therapy intervention is done and no home-based walking exercise is required either.

Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Kachexia (BMI\<18.5)
• instable bone metastases
• orthopedic condition rendering the patient unable to ride a stationary bike
• any medical contraindication for exercise and training

Sponsors & Collaborators

• Medical University of Graz: lead
• University of Graz: collaborator
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

Medical University of Graz

Graz, 8076, Austria

Location

Related Publications (6)

• Martin-Ruiz A, Fiuza-Luces C, Rincon-Castanedo C, Fernandez-Moreno D, Galvez BG, Martinez-Martinez E, Martin-Acosta P, Coronado MJ, Franco-Luzon L, Gonzalez-Murillo A, Ramirez M, Provencio M, Lucia A. Benefits of exercise and immunotherapy in a murine model of human non-small-cell lung carcinoma. Exerc Immunol Rev. 2020;26:100-115.

  PMID: 32139351 BACKGROUND

• Ungvari Z, Fekete M, Varga P, Munkacsy G, Fekete JT, Lehoczki A, Buda A, Kiss C, Ungvari A, Gyorffy B. Exercise and survival benefit in cancer patients: evidence from a comprehensive meta-analysis. Geroscience. 2025 Jun;47(3):5235-5255. doi: 10.1007/s11357-025-01647-0. Epub 2025 Apr 12.

  PMID: 40220151 BACKGROUND

• Winters-Stone KM, Neil SE, Campbell KL. Attention to principles of exercise training: a review of exercise studies for survivors of cancers other than breast. Br J Sports Med. 2014 Jun;48(12):987-95. doi: 10.1136/bjsports-2012-091732. Epub 2013 Jan 4.

  PMID: 23293010 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

• Rezende LFM, Sa TH, Markozannes G, Rey-Lopez JP, Lee IM, Tsilidis KK, Ioannidis JPA, Eluf-Neto J. Physical activity and cancer: an umbrella review of the literature including 22 major anatomical sites and 770 000 cancer cases. Br J Sports Med. 2018 Jul;52(13):826-833. doi: 10.1136/bjsports-2017-098391. Epub 2017 Nov 16.

  PMID: 29146752 BACKGROUND

• Ashcraft KA, Peace RM, Betof AS, Dewhirst MW, Jones LW. Efficacy and Mechanisms of Aerobic Exercise on Cancer Initiation, Progression, and Metastasis: A Critical Systematic Review of In Vivo Preclinical Data. Cancer Res. 2016 Jul 15;76(14):4032-50. doi: 10.1158/0008-5472.CAN-16-0887. Epub 2016 Jul 5.

  PMID: 27381680 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Elisabeth Taucher, Dr. Dr.

CONTACT

+436648438876; elisabeth.taucher@medunigraz.at

Peter Hofmann, Prof. Mag. Dr.

CONTACT

+43 316 380 3903

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

AU (1)