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
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
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Not yet recruiting |
| Careggi University Hospital | Florence | Italy | Not yet recruiting |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Not yet recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Italy | Not yet recruiting |
| Istituto Oncologico Veneto | Padova | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Parma | Parma | Italy | Not yet recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Not yet recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Not yet recruiting |
| Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa Chiara | Trento | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.