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 | Recruiting

• 1 other identifier: INT128/22
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

NSCLC; Cancer; Lung Cancer; Adenocarcinoma of Lung; Squamous Cell Lung Cancer

Keywords

#NSCLC; #Immunotherapy; #Targeted Therapy; #Artificial Intelligence

Outcome Measures

Primary Outcomes (3)

• Response Rate

  Prediction of response to innovative therapies in NSCLC patients

  About 8 weeks (first radiological evaluation)

• Progression-Free Survival

  Prediction of Progression-Free Survival in NSCLC patients treated with innovative therapies

  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

• Overall Survival

  Prediction of Overall Survival in NSCLC patients treated with innovative therapies

  From data of enrollment until the date of death from any cause, assessed up to 120 months

Study Arms (2)

Retrospective Cohort

About 1000 patients with NSCLC pre-treated with innovative therapy (e.g. immunotherapy, targeted therapy) will be included.

Prospective Cohort

About 200 patients with NSCLC planned to start an innovative therapy (e.g. immunotherapy, targeted therapy) will be included.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with NSCLC treated with innovative therapies in different Italian Centers will be enrolled in retrospective and prospective cohorts.

You may qualify if:

• 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;
• Patients must be ≥18 years of age at the time of signing the informed consent;
• 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).

You may not qualify if:

• Patients who are or will be taking other unapproved antineoplastic therapies concurrently are not eligible.
• Patients who have not received an oncological systemic innovative therapy at any setting
• Patients received only local treatments (e.g., only surgery, or only radiotherapy)
• Patients who received only standard chemotherapy are excluded.
• Patients who received treatment therapies before 2010 are excluded.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Politecnico di Milano: collaborator
• Ospedale Policlinico San Martino: collaborator
• Insieme per i Pazienti di Oncologia Polmonare Onlus (IPOP): collaborator
• ASST Grande Ospedale Metropolitano Niguarda: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• Azienda Ospedaliera dei Colli: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Azienda Ospedaliera S. Maria della Misericordia: collaborator
• Azienda Ospedaliera "Sant'Andrea": collaborator
• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• Azienda Ospedaliero, Universitaria Ospedali Riuniti: collaborator
• Istituto Clinico Humanitas: collaborator
• Azienda Unità Sanitaria Locale della Romagna: collaborator
• Istituti Ospitalieri di Cremona: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

RECRUITING

Related Links

• IPOP website describing APOLLO 11 project

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Carlo Genova

  IRCCS Ospedale Policlinico San Martino, Genova

  PRINCIPAL INVESTIGATOR

• Diego Signorelli

  ASST Grande Ospedale Metropolitano Niguarda, Milano

  PRINCIPAL INVESTIGATOR

• Carminia Maria Della Corte

  Azienda Ospedaliera Universitaria - Università degli Studi della Campania "Luigi Vanvitelli", Napoli

  PRINCIPAL INVESTIGATOR

• Giuseppe Viscardi

  Ospedale Monaldi, Azienda Ospedaliera Dei Colli, Monaldi, Napoli

  PRINCIPAL INVESTIGATOR

• Giulia Galli

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

• Giulio Metro

  Azienda Ospedaliera Santa Maria della Misercordia, Perugia

  PRINCIPAL INVESTIGATOR

• Raffaele Giusti

  Azienda Ospedaliera Univesitaria S. Andrea, Roma

  PRINCIPAL INVESTIGATOR

• Marianna Macerelli

  Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia, Udine

  PRINCIPAL INVESTIGATOR

• Alessandro Inno

  IRCCS Ospedale sacro Cuore Don Calabria NEGRAR

  PRINCIPAL INVESTIGATOR

• Rossana Berardi

  A.O. universitaria Ospedali Riuniti di Ancona

  PRINCIPAL INVESTIGATOR

• Luca Toschi

  Fondazione IRCCS Istituto clinico Humanitas

  PRINCIPAL INVESTIGATOR

• Michela Spreafico

  Azienda Unità Sanitaria Locale della Romagna, Ravenna

  PRINCIPAL INVESTIGATOR

• Nicoletta Nanni

  ASST Ospedale Cremona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arsela Prelaj, M.D.

CONTACT

+390223903647; arsela.prelaj@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

IT (1)