Project Funding Details

A healthier lifestyle (not smoking, maintaining a healthy weight, exercising regularly) could have avoided >1,600,000 lung-cancer-related deaths in 2019. Lifestyle interventions positively impact on lung cancer natural history across all disease stages. However, solid clinical evidence of the impact of lifestyle interventions on hard clinical endpoints (e.g., cure rates) in early-stage disease is currently lacking. STARLighT builds on the hypothesis that implementing a structured lifestyle intervention together with systemic neoadjuvant/adjuvant treatment would significantly improve clinical outcomes in patients with early-stage lung cancer and reduce the socio-economic burden caused by this disease, while substantially improving patients' quality-of-life. The primary aim of the STARLighT trial is to test the impact of a structured and evidence-based lifestyle intervention delivered by the user-friendly portable interface (e-ALLY) on pathological complete response (pCR) in patients undergoing neoadjuvant treatments and on disease-free survival (DFS) in patients undergoing adjuvant therapies. Translational studies will allow understanding the biological and molecular mechanisms of action of lifestyle interventions, thereby generating novel biological knowledge and leading to progressive refinement of intervention strategies. A master clinical protocol will be set up to evaluate e-ALLY assisted lifestyle intervention in different cohorts of patients diagnosed with non-oncogene addicted with early-stage NSCLC (stages IB to IIIA). COHORT A will accrue 35 patients undergoing neoadjuvant chemo/immunotherapy and exploit a single-arm phase II design to detect an increase in the proportion of pathological complete response (pCR) from 20% to 40%; COHORT B will accrue 216 patients undergoing physician's choice of adjuvant treatment and exploit a 2:1 randomized controlled design to detect an increase in 2-year disease-free survival (DFS) rates from 55% to 70% in the control and experimental arms, respectively. All patients in COHORT A and patients randomized to the experimental arm in COHORT B will receive a tailored, evidence-based lifestyle intervention (physical exercise, nutritional, behavioral support), based on the treatment setting and delivered through a telehealth system (e-ALLY), developed within the current project; patients allocated to the control arm (COHORT B) will receive the current standard of care and dedicated educational health material. Translational studies will encompass baseline assessment of genomic and transcriptomic features and longitudinal assessment of circulating immuno-inflammatory profiles and tumor microenvironment composition, to be correlated with clinical and lifestyle data, to build a comprehensive predictive model and to refine the e-ALLY-based intervention. We expect that a tailored lifestyle intervention will result in a higher pCR rate and longer DFS in patients in the neoadjuvant or adjuvant setting, respectively, thereby potentially increasing cure rates in early NSCLC. New biological knowledge is expected to be generated by translational studies, paving the way for even more effective future lifestyle-based interventions. The ambitious aim of STARLighT is to provide solid evidence for affordable, easily implementable, patient-centered lifestyle interventions to reduce lung cancer mortality. Not secondarily, we expect such interventions to result in improved efficacy of current treatments, better patients' quality of life, and improved physical and psychological well-being of lung cancer survivors.