Clinical trial NCT05550961: APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch
Official title: APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Cancer
Lung Cancer
Adenocarcinoma of Lung
Squamous Cell Lung Cancer
Keywords: #NSCLC
#Immunotherapy
#Targeted Therapy
#Artificial Intelligence
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
name: Ospedale Policlinico San Martino
name: Insieme per i Pazienti di Oncologia Polmonare Onlus (IPOP)
name: ASST Grande Ospedale Metropolitano Niguarda
name: University of Campania Luigi Vanvitelli
name: Azienda Ospedaliera dei Colli
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Azienda Ospedaliera S. Maria della Misericordia
name: Azienda Ospedaliera "Sant'Andrea"
name: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: Azienda Ospedaliero, Universitaria Ospedali Riuniti
name: Istituto Clinico Humanitas
name: Azienda Unità Sanitaria Locale della Romagna
name: Istituti Ospitalieri di Cremona
First posted: 2022-09-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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".

Detailed description: With the advent of several innovative therapies ("target" therapies, immunotherapy (IO) and/or next generation therapies), the identification of prognostic/predictive and/or resistance biomarkers represents the main goals of translational research in advanced lung cancer (aLC). In particular, with the arrival of IO the treatment landscape of advanced Non-Small Cell Lung Cancer (NSCLC) patients (pts), have radically changed prolonging significantly the overall survival (OS). The role of Programmed Death Ligand 1 (PD-L1) remains undefined and to date no other biomarker are used to select patients for IO. Artificial Intelligence (AI) frameworks, which synthesize and correlate information from different data sources, is a potentially highly efficient instrument to construct algorithms reinforcing the individualized prediction.

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 and a "virtual" multilevel biobank. This will allow to avoid worthless dispersion of single institution data, which often remaine unused and inconclusive due to limited number of patients and low statistical power. Besides, APOLLO 11 will take advantage of the translational research joint effort with the credo "unity is strength". The multilevel structure is designed also for smallest centres of give them possibility to contribute to biobank looking at their internal facilities.

APOLLO 11 have the goal to establish the consortium by fully activating at least 20 of the 48 involved centres able to collect data within the database and to guarantee the activation ready for at least 10 biobanks able to collect samples (tumour tissue, blood, stool and urine). Moreover, the key scientific aim of the project is to provide answers about aNSCLC pts treated with IO. In particular, try to find a "software" biomarker able to better predict IO selection compare to standard of care single biomarker (e.g., PD-L1, TMB) using artificial intelligence/machine/deep learning (AI/DL/ML) methodologies. Real world (demographic, histology, PD-L1, molecular, treatment and outcomes information etc), radiomics and where available (from previous researches) multiomic data from all the activated centres will be collected. Furthermore, single-cell RNA sequencing (scRNA seq) analysis will be carry out. Finally, AI/ML/DL will be used to integrate the multisource data, analyse them and develop predictive algorithms of IO efficacy in NSCLC pts. Explainable trustworthy AI (XAI) methodology will be used in order to better understand black box for explaining clinical and biological insight.

Eligibility 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.

Primary outcomes:
measure: Response Rate
timeFrame: About 8 weeks (first radiological evaluation)
measure: Progression-Free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: From data of enrollment until the date of death from any cause, assessed up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: IRCCS Ospedale Policlinico San Martino, Genova
name: Carlo Genova
role: PRINCIPAL_INVESTIGATOR
affiliation: ASST Grande Ospedale Metropolitano Niguarda, Milano
name: Diego Signorelli
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria - Università degli Studi della Campania "Luigi Vanvitelli", Napoli
name: Carminia Maria Della Corte
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Monaldi, Azienda Ospedaliera Dei Colli, Monaldi, Napoli
name: Giuseppe Viscardi
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Giulia Galli
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Santa Maria della Misercordia, Perugia
name: Giulio Metro
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Univesitaria S. Andrea, Roma
name: Raffaele Giusti
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia, Udine
name: Marianna Macerelli
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Ospedale sacro Cuore Don Calabria NEGRAR
name: Alessandro Inno
role: PRINCIPAL_INVESTIGATOR
affiliation: A.O. universitaria Ospedali Riuniti di Ancona
name: Rossana Berardi
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Istituto clinico Humanitas
name: Luca Toschi
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Unità Sanitaria Locale della Romagna, Ravenna
name: Michela Spreafico
role: PRINCIPAL_INVESTIGATOR
affiliation: ASST Ospedale Cremona
name: Nicoletta Nanni
role: PRINCIPAL_INVESTIGATOR
References: