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Recruiting Observational

APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch

NCT05550961 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-10-01
Last updated
2023-10-23

Condition(s) studied

NSCLCCancerLung CancerAdenocarcinoma of LungSquamous Cell Lung Cancer

Study summary

APOLLO 11 main aim is to build a strong Italian long-lasting lung cancer network (in around 48 Italian centres) on real world data and translational research by creating a decentralized long-term national database (settle locally in each centre) and a "virtual" multilevel biobank in each centre. Besides, APOLLO 11 will take advantage of the translational research joint effort with the credo "unity is strength".

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Response Rate — About 8 weeks (first radiological evaluation)
    Prediction of response to innovative therapies in NSCLC patients
  • Progression-Free Survival — From data of enrollment until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 120 months
    Prediction of Progression-Free Survival in NSCLC patients treated with innovative therapies
  • Overall Survival — From data of enrollment until the date of death from any cause, assessed up to 120 months
    Prediction of Overall Survival in NSCLC patients treated with innovative therapies

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05550961 on ClinicalTrials.gov ↗ ← All trials in Italy