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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)
EU CTIS ID: 2024-517445-13-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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.
You likely can't join if
- • 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.)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.