FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
The primary objective is to determine the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the first-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of study entry;
Locally documented histological diagnosis of Large-Cell NeuroEndocrine Carcinoma of the lung (2021 WHO classification of Lung Tumors );
Patient must have sufficient material to achieve central histological confirmation and exploratory analyses (1 representative FFPE block or at least 10 unstained slides);
Setting of the disease: locally advanced (Stage III) not eligible for loco-regional therapy or metastatic (Stage IV) in first line treatment (8th TNM classification).
Disqualifiers
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study (wash-out period of 28 days);
Patient previously treated for a LCNEC in a metastatic setting;
Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab;
Any concurrent chemotherapy, Investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable;
Trial design
Treatments tested in this trial
- Durvalumab with etoposide and Carboplatin/Cisplatin
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Centre Leon Berard
Lead sponsor
Groupe Francais De Pneumo-Cancerologie
Collaborator
Source ClinicalTrials.gov