An observational study in NSCLC, Cancer and Lung Cancer, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational
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".
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with NSCLC treated with innovative therapies in different Italian Centers will be enrolled in retrospective and prospective cohorts.
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Exclusion Criteria:
About 1000 patients with NSCLC pre-treated with innovative therapy (e.g. immunotherapy, targeted therapy) will be included.
About 200 patients with NSCLC planned to start an innovative therapy (e.g. immunotherapy, targeted therapy) will be included.
Response Rate
Prediction of response to innovative therapies in NSCLC patients
Time frame: About 8 weeks (first radiological evaluation)
Progression-Free Survival
Prediction of Progression-Free Survival in NSCLC patients treated with innovative therapies
Time frame: 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
Time frame: From data of enrollment until the date of death from any cause, assessed up to 120 months
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