Building a national network for lung cancer treatment in Italy
APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch
This study is trying to create a nationwide network in Italy to gather information and improve treatments for advanced lung cancer patients using new therapies like immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT05550961 on ClinicalTrials.gov |
What this trial studies
The APOLLO 11 initiative aims to establish a comprehensive network across approximately 48 Italian centers to collect real-world data and conduct translational research on lung cancer. This project focuses on advanced lung cancer patients receiving innovative therapies, including immunotherapy and targeted treatments. By creating a decentralized national database and a virtual biobank, the study seeks to enhance the understanding of prognostic and predictive biomarkers, particularly in the context of immunotherapy. The integration of artificial intelligence will facilitate the development of algorithms for personalized treatment predictions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically or cytologically confirmed lung cancer who are receiving or have received innovative therapies.
Not a fit: Patients who have only undergone local treatments or standard chemotherapy, or those taking unapproved antineoplastic therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly improve treatment outcomes for lung cancer patients by identifying effective biomarkers and optimizing therapy selection.
How similar studies have performed: Other studies utilizing real-world data and translational research in lung cancer have shown promise, indicating that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated written informed consent, when applicable, by the patient or legally acceptable representative prior to any mandatory study-specific procedures, sampling, and analyses; 2. Patients must be ≥18 years of age at the time of signing the informed consent; 3. Histologically or cytologically confirmed lung cancer (NSCLC or SCLC) at any stage (I-IV) candidate to receive or already treated with innovative therapies (ICIs, target therapies and next generation therapies). Exclusion Criteria: 1. Patients who are or will be taking other unapproved antineoplastic therapies concurrently are not eligible. 2. Patients who have not received an oncological systemic innovative therapy at any setting 3. Patients received only local treatments (e.g., only surgery, or only radiotherapy) 4. Patients who received only standard chemotherapy are excluded. 5. Patients who received treatment therapies before 2010 are excluded.
Where this trial is running
Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Genova — IRCCS Ospedale Policlinico San Martino, Genova
- Study coordinator: Arsela Prelaj, M.D.
- Email: arsela.prelaj@istitutotumori.mi.it
- Phone: +390223903647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.