1435P - Clinical and molecular study with digital support of advanced non-small cell lung cancer patients: SNF-CLIMEDIN, a prospective randomized Hellenic Cooperative Oncology Group (HeCOG) study: Interim analysis

Background

SNF-CLIMEDIN aims to provide comprehensive care to advanced NSCLC patients through 3 pillars: clinical, molecular and digital. Molecular profiling is not yet reimbursed. In the era of new therapies remote support tools are needed.

Methods

In this prospective randomized non-interventional study in 200 NSCLC patients receiving standard 1^st line therapy, 161 genes are analyzed via NGS. Clinicians report Adverse Events (AEs) in a study database; patients record AEs in a digital platform and are randomized to receive (investigational) or not (control) educational and supportive content. The impact of digital support on QoL is evaluated.

Results

This unplanned interim analysis studied 100 patients from 15 HeCOG centres. The Table shows clinical and molecular characteristics. The most common 1^st line therapy was IO-chemo (80%). PR was 32%, SD 31%, 1-yr OS 64%, med PFS 5 months and med OS 8 months. Clinicians reported fatigue, haematological, liver and skin toxicities as the commonest gr3-4 AEs, while patients in the platform most often reported fatigue, cough, nausea, diarrhoea and anorexia. More AEs were reported in the platform than in the study database (89% vs 68% of patients, p<0.05). Platform use was higher in the investigational arm and rural areas. Patient-reported AE improvement was 78.4% (80.8% investigational vs 75.8% control). Most pts reporting AEs at least twice had ≥50% improvement. QoL and socio-demographic correlations with digital platform use will be presented. Table: 1435P

Conclusions

The study provides prospective evidence on NSCLC patients’ clinical and molecular profiles, treatment patterns and outcomes. Digital education and support led to increased AE reports and improvements, especially in the investigational arm. Socio-demographic factors influenced platform engagement, highlighting the significance of digital initiatives for patient-centered NSCLC care.

Clinical trial identification

NCT05372081.

Editorial acknowledgement

Legal entity responsible for the study

Hellenic Cooperative Oncology Group.

Funding

Stavros Niarchos Foundation donation.

Disclosure

H. Linardou: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, Merck, Takeda, Bristol Myers Squibb, Lilly, Pfizer; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, Bristol Myers Squibb, Pfizer, Amgen, Novartis; Financial Interests, Personal and Institutional, Local PI: Bristol Myers Squibb, Boehringer Ingelheim, Roche, AbbVie, Lilly, Novartis, AstraZeneca, Amgen, PPD, Parexel ILR, Qualitis, Health Data Specialist; Non-Financial Interests, Principal Investigator: Hellenic Cooperative Oncology Group; Non-Financial Interests, Leadership Role, Elected President of the Scientific Committee: Hellenic Cooperative Oncology Group; Non-Financial Interests, Member of Board of Directors: Women 4 Oncology - Hellas, Fairlife Lung Cancer Care. E. Fountzilas: Financial Interests, Personal, Other, travel grant: AstraZeneca, Genesis Pharma; Financial Interests, Personal, Invited Speaker: Roche, GSK, Amgen, Pfizer, AstraZeneca; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Stocks or ownership: Deciphera Pharmaceuticals, Inc. . A. Psyrri: Financial Interests, Personal, Invited Speaker: MSD, Merck Serono; Financial Interests, Personal, Advisory Board: Pfizer, Sanofi, MSD, AstraZeneca, BMS, Leo, Rakuten, eTheRNA immunotherapies, Merck Serono; Financial Interests, Personal and Institutional, Local PI: AstraZeneca, Pfizer, GSK, Genesis, MSD, Incyte, Amgen, Debiopharm, Janssen, Lilly, Regeneron, Sanofi, BI, Roche, Peregrine, Oncolytics Biotech; Financial Interests, Coordinating PI: AstraZeneca; Financial Interests, Personal and Institutional, Steering Committee Member: Iovance, Pfizer, Roche; Financial Interests, Institutional, Steering Committee Member: Kura Oncology; Financial Interests, Steering Committee Member: Kura Oncology; Financial Interests, Personal and Institutional, Funding: Kura Oncology, BMS, Roche, Demo, Amgen, BI, Genesis, BMS, Pfizer, Oncolytics Biotech; Financial Interests, Institutional, Funding: Merck Serono, Pfizer; Financial Interests, Personal, Other, Educational activity: Medscape, PrimeOncology; Financial Interests, Institutional, Local PI: Novartis, Replimmune; Non-Financial Interests, Project Lead, Medical Education with honoraria: Medscape. G. Mountzios: Financial Interests, Personal, Advisory Board: Roche, BMS, Takeda, Janssen; Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, Pfizer, Novartis, Amgen. J.I. Sgouros: Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Institutional, Research Funding: Demo S.A., Innovis, Rafarm, WinMedica. G. Fountzilas: Financial Interests, Personal, Advisory Board: Pfizer, Novartis; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Novartis; Financial Interests, Personal, Stocks/Shares: Genprex, Daiichi Sankyo , Formycon, RFL Holdings. P.A. Kosmidis: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Other, Registration in Congress: Pfizer; Financial Interests, Personal, Other, Registration to Congress: Sanofi; Financial Interests, Personal, Ownership Interest: Careacross Digital Health Company. All other authors have declared no conflicts of interest.