NSCLCNCT05550961
APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch
An observational study of NSCLC and Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Cancer, Lung Cancer
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 1 Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSCLC treated with innovative therapies in different Italian Centers will be enrolled in retrospective and prospective cohorts.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Arsela Prelaj, MD
About this study
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".
Read the 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.
- Conditions
- NSCLC, Cancer, Lung Cancer, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Keywords
- #NSCLC, #Immunotherapy, #Targeted Therapy, #Artificial Intelligence
- Medical subject headings
- Neoplasms, Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Prediction of response to innovative therapies in NSCLC patients
Measured: About 8 weeks (first radiological evaluation)
Progression-Free Survival
Prediction of Progression-Free Survival in NSCLC patients treated with innovative therapies
Measured: 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
Measured: From data of enrollment until the date of death from any cause, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, Ospedale Policlinico San Martino, Insieme per i Pazienti di Oncologia Polmonare Onlus (IPOP), ASST Grande Ospedale Metropolitano Niguarda, University of Campania Luigi Vanvitelli, Azienda Ospedaliera dei Colli, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliera S. Maria della Misericordia, Azienda Ospedaliera "Sant'Andrea", Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, IRCCS Sacro Cuore Don Calabria di Negrar, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Istituto Clinico Humanitas, Azienda Unità Sanitaria Locale della Romagna, Istituti Ospitalieri di Cremona
- Responsible party
- Principal investigator, Arsela Prelaj, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Carlo Genova, Principal investigator, IRCCS Ospedale Policlinico San Martino, GenovaDiego Signorelli, Principal investigator, ASST Grande Ospedale Metropolitano Niguarda, MilanoCarminia Maria Della Corte, Principal investigator, Azienda Ospedaliera Universitaria - Università degli Studi della Campania "Luigi Vanvitelli", NapoliGiuseppe Viscardi, Principal investigator, Ospedale Monaldi, Azienda Ospedaliera Dei Colli, Monaldi, NapoliGiulia Galli, Principal investigator, Fondazione IRCCS Policlinico San Matteo di PaviaGiulio Metro, Principal investigator, Azienda Ospedaliera Santa Maria della Misercordia, PerugiaRaffaele Giusti, Principal investigator, Azienda Ospedaliera Univesitaria S. Andrea, RomaMarianna Macerelli, Principal investigator, Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia, Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550961
- Sponsor's protocol ID
- INT128/22
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05550961
- Acronym / sponsor ID
- INT128/22
- Conditions
- NSCLC, Cancer, Lung Cancer, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Keywords
- #NSCLC, #Immunotherapy, #Targeted Therapy, #Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Politecnico di Milano, Ospedale Policlinico San Martino, Insieme per i Pazienti di Oncologia Polmonare Onlus (IPOP), ASST Grande Ospedale Metropolitano Niguarda, University of Campania Luigi Vanvitelli, Azienda Ospedaliera dei Colli, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliera S. Maria della Misericordia, Azienda Ospedaliera "Sant'Andrea", Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, IRCCS Sacro Cuore Don Calabria di Negrar, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Istituto Clinico Humanitas, Azienda Unità Sanitaria Locale della Romagna, Istituti Ospitalieri di Cremona
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC treated with innovative therapies in different Italian Centers will be enrolled in retrospective and prospective cohorts.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response Rate
Time frame: About 8 weeks (first radiological evaluation)
Prediction of response to innovative therapies in NSCLC patients
Progression-Free Survival
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
Prediction of Progression-Free Survival in NSCLC patients treated with innovative therapies
Overall Survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- IPOP website describing APOLLO 11 projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo Genova principal investigator
IRCCS Ospedale Policlinico San Martino, Genova
Diego Signorelli principal investigator
ASST Grande Ospedale Metropolitano Niguarda, Milano
Carminia Maria Della Corte principal investigator
Azienda Ospedaliera Universitaria - Università degli Studi della Campania "Luigi Vanvitelli", Napoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arsela Prelaj, M.D. (+390223903647, arsela.prelaj@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: About 8 weeks (first radiological evaluation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.