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

ConditionsNSCLCCancerLung CancerAdenocarcinoma of LungSquamous Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups
Group A: Retrospective Cohort
Group B: Prospective Cohort

Trial outcomes

Primary outcomes

1

Response Rate

Prediction of response to innovative therapies in NSCLC patients

Time frame
About 8 weeks (first radiological evaluation)
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

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

Source ClinicalTrials.gov
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