Structured exercise and nutrition program for people with early-stage non-small cell lung cancer
Official title: PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
Run by Universita di Verona · NCT07042724 · Data updated 2026-11-12
This trial tests whether a structured exercise and nutrition program can improve treatment response and disease-free survival for people with early-stage non-small cell lung cancer receiving neoadjuvant or adjuvant therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 324 (estimated) |
| Sponsor | Universita di Verona Academic / other |
| Locations | 1 site (Verona) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | April 30, 2030 |
| Study ends | April 30, 2030 |
| Registry record updated | June 29, 2025 |
| Trial ID | NCT07042724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with resectable or resected non–oncogene-addicted NSCLC (stage IB–IIIB), ECOG performance status 0–1, who are scheduled for or receiving neoadjuvant or adjuvant systemic therapy and are willing to use the study's monitoring device.
✕Probably not a fit
Patients with absolute contraindications to exercise (for example unstable cardiac disease or uncontrolled hypertension), those requiring artificial nutrition, with severely reduced mobility, severe organ dysfunction, or tumors with targetable oncogene alterations are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
STARLighT enrolls two cohorts of patients with resectable or resected EGFR/ALK wild-type NSCLC (stage IB–IIIB): one cohort undergoing neoadjuvant therapy and one undergoing adjuvant therapy. Participants receive a structured physical exercise and nutritional program throughout their anticancer treatment, plus health education materials and a monitoring device, while comparators receive usual care. Key outcomes include pathological complete response in the neoadjuvant cohort and disease-free survival in the adjuvant cohort, with additional measures of fitness, nutritional status, and treatment tolerability. The trial is single-center at Verona Hospital and requires participants to have ECOG 0–1 and provide informed consent.
Why it matters
Potential benefit: If successful, the program could increase rates of complete tumor response, extend disease-free survival, and improve patients' physical fitness and nutritional status during treatment.
How similar studies have gone: Previous cancer rehabilitation studies have shown that exercise and nutritional support can improve fitness, reduce complications, and enhance quality of life, but evidence that they specifically increase pathological complete response or disease-free survival in early-stage NSCLC is limited, making this application relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * age ≥ 18 years. * confirmed diagnosis of resectable or resected non-oncogene addicted NSCLC (EGFR, ALK wild-type). * stage IB to IIIB. * candidate or undergoing systemic treatment. * ECOG performance status 0-1. * written informed consent. * willingness to use the technology/device specifically developed for patients' monitoring and support within the trial. Exclusion criteria * evidence in the medical record of absolute contraindications to exercise, nutritional, or psychological intervention \[i.e., heart insufficiency; uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction, bone marrow insufficiency); reduced standing or walking ability; myocardial infarction\]. * indications for or ongoing artificial nutrition support (totally compromised spontaneous food intake). * incapacity, or unavailability to consume oral nutritional supplements.
Where it's running
-
Verona Hospital
Verona, Italy Recruiting
Study contacts
- Principal investigator: Sara Pilotto, Ph.D., MD — Universita di Verona
- Study coordinator: Alice Avancini, Ph.D.
- Email: alice.avancini@univr.it
- Phone: +39 3403624264
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Understanding what patients want from NSCLC treatment monitoring
Researchers are testing how patients with non-small cell lung cancer feel about and prefer monitoring their symptoms during treatment, with input from patients, caregivers, and clinicians.
-
PD-L1-targeted PET probe to map PD-L1 in solid tumors
A PET tracer called 18F-F-PDL1-3 is being tested to see if it can detect PD-L1 expression in primary and metastatic tumors to help guide personalized treatment.
-
Cardiorespiratory fitness after lobectomy versus sublobar resection in NSCLC
This study tests how different lung surgeries (lobectomy vs. sublobar resection) affect fitness levels after surgery in people with non-small cell lung cancer.
-
CAIX-targeted PET/CT imaging in solid tumors
Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.
-
NUT Project: Nutritional Support in Thoracic Cancer
We’ll see if providing tailored nutrition guidance and assessment helps people with advanced lung cancer during their treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.