Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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HER2 in Advanced NSCLC: an Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in Italy. The HEROS Study - GOIRC-01-2022

Status: Recruiting
Location: See all (22) locations...
Study Type: Observational
SUMMARY

The HEROS study is an Italian observational multicenter prospective study aimed to investigate the current diagnostic and therapeutical approach towards HER2 mutated NSCLC in clinical practice. The enrolment will start in September 2024 until September 2025. A 12-months follow-up window will be performed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Cohort 1 (Prevalence study population)

• Male or female, aged at least 18 years.

• Pathologically confirmed diagnosis of NSCLC from September 2024 to September 2025.

• Locally advanced (IIIC), not amenable to multimodal approach (chemo-radiotherapy), or metastatic (IV) NSCLC according to TNM VIII edition.

• Enrolled in ATLAS project. Cohort 2 (HER2 mutations study population)

• Included in Cohort 1.

• Presence of HER2 mutation.

• Enrolled in ATLAS project. Cohort 3 (Prospective Biomarker Analysis population)

• Included in Cohort 2.

• Availability of tissue sample from the first 50 patients enrolled in cohort 2.

⁃ Written informed consent (HEROS project) must be obtained before any study-related procedure.

Locations
Other Locations
Italy
Centro di Riferimento Oncologico IRCCS di Aviano
NOT_YET_RECRUITING
Aviano
IRCCS Giovanni Paolo II
ACTIVE_NOT_RECRUITING
Bari
Arcispedale Sant'Anna
NOT_YET_RECRUITING
Ferrara
Ospedale Policlinico San Martino
NOT_YET_RECRUITING
Genova
Ospedale Versilia
ACTIVE_NOT_RECRUITING
Lido Di Camaiore
Azienda Sanitaria Toscana Nord - Ovest
ACTIVE_NOT_RECRUITING
Lucca
Istituto Romagnolo per lo Studio dei Tumori IRST Dino Amadori
NOT_YET_RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero - Universitaria di Modena
ACTIVE_NOT_RECRUITING
Modena
IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
AOU San Luigi Orbassano
NOT_YET_RECRUITING
Orbassano
Istituto Oncologico Veneto IRCCS
RECRUITING
Padova
Azienda Ospedaliera - Universitaria di Parma
RECRUITING
Parma
Fondazione IRCCS Policlinico S. Matteo
NOT_YET_RECRUITING
Pavia
Azienda Ospedaliera di Perugia
ACTIVE_NOT_RECRUITING
Perugia
Azienda Ospedaliero - Universitaria di Reggio Emilia
ACTIVE_NOT_RECRUITING
Reggio Emilia
Azienda Ospedaliera San Camillo Forlanini
ACTIVE_NOT_RECRUITING
Roma
Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO
NOT_YET_RECRUITING
Roma
Istituto Clinico Humanitas IRRCS
NOT_YET_RECRUITING
Rozzano
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
NOT_YET_RECRUITING
Udine
Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Marcello Tiseo, MD, PhD
goirc-heros@goirc.org
+390521704465
Backup
Alessandro Leonetti, MD, PhD
info@goirc.org
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 50
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Collaborators: AstraZeneca
Leads: Gruppo Oncologico Italiano di Ricerca Clinica

This content was sourced from clinicaltrials.gov

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