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)
Key facts
- Where
- Brescia, Florence, Genoa, Modena, Negrar, Padova, Parma, Pavia, Reggio Emilia és Trento, OlaszországSee the 10 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországToborzás még nem indult
- Careggi University HospitalFlorence, OlaszországToborzás még nem indult
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországToborzás még nem indult
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországToborzás még nem indult
- IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, OlaszországToborzás még nem indult
- Istituto Oncologico VenetoPadova, OlaszországToborzás még nem indult
- Azienda Ospedaliero Universitaria ParmaParma, OlaszországToborzás még nem indult
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországToborzás még nem indult
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, OlaszországToborzás még nem indult
- Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa ChiaraTrento, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliero Universitaria Di Modena
- Trial code
- EU 2024-517445-13-00
- Record updated
- 2024. november 11.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.).