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2024-517445-13-00Not yet recruitingPhase 2

A Phase II, open label, single arm, multicentre study on THOracic Radiotherapy in Extensive Stage SCLC patients submitted to first line CHT-RT plus Durvalumab (MEDI4736)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

To assess the efficacy of first line chemo-immunotherapy with cisplatin/carboplatin, etoposide plus durvalumab followed by consolidation durvalumab monotherapy and concomitant thoracic radiation therapy by assessment of 12-Months progression-free survival (PFS, defined as time from enrollment to the date of objective disease progression both locoregionally and/or systemically) or death for any cause in the absence of progression of disease) in extensive stage SCLC patients.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
94 (estimated)
First submitted
15 Oct 2024
Start date
1 Jan 2025
Lead sponsor
Azienda Ospedaliero Universitaria Di Modena
Diseases
Lung cancer
EU CT number
2024-517445-13-00
EudraCT number
2021-006578-21

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 94
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Histology of non-small cell lung cancer • Limited-stage SCLC • Previous immunotherapy of any type • Contraindication for immunotherapy (active or previous autoimmune or inflammatory disorders) • Primary immunodeficiency • Acute/chronic respiratory failure • Presence of symptomatic or progressive brain metastases • Other contraindications that do not allow radiotherapy (inflammatory interstitial lung disease, etc.)

Who the study is looking for

  • Large-stage small cell lung cancer confirmed by histology • Imaging at diagnosis: chest/abdominal CT + bone scan (or 18 FDG PET CT) + brain MRI, • CR, PR, or SD after first-line platinum-based chemotherapy plus Durvalumab for up to 4 cycles • Candidate for maintenance immunotherapy with Durvalumab • ECOG Performance Status 0-2 • Normal lung functions • Planning target volume < 600 cc • Body weight >30 kg • Able to sign informed consent • Age >18 years but < 80 years • No previous thoracic radiotherapy • Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use a highly effective method of contraception during the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (10)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBresciaItalyNot yet recruiting
Careggi University HospitalFlorenceItalyNot yet recruiting
IRCCS Ospedale Policlinico San MartinoGenoaItalyNot yet recruiting
Azienda Ospedaliero - Universitaria di ModenaModenaItalyNot yet recruiting
IRCCS Ospedale Sacro Cuore Don CalabriaNegrarItalyNot yet recruiting
Istituto Oncologico VenetoPadovaItalyNot yet recruiting
Azienda Ospedaliero Universitaria ParmaParmaItalyNot yet recruiting
Fondazione IRCCS Policlinico San MatteoPaviaItalyNot yet recruiting
Azienda USL IRCCS di Reggio EmiliaReggio EmiliaItalyNot yet recruiting
Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa ChiaraTrentoItalyNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.