FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum

Sponsor
Centre Leon Berard
Study ID
NCT06393816
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large Cell Neuroendocrine Carcinoma of the Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab with etoposide and Carboplatin/Cisplatin — DRUG
    Combination of durvalumab with etoposide and Carboplatin/Cisplatin as First Line Treatment in Patients With Large-cell Neuroendocrine Carcinomas of the Lung. All patients (either with confirmed diagnosis or not) will be treated and followed-up: * During the induction: every 3 weeks for 12 weeks (4 cycles) * During the maintenance: every 4 weeks for 24 months

Study Details

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

Key Dates

Start date
Jun 13, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental : Durvalumab with etoposide and Carboplatin/Cisplatin
    Combination of durvalumab with etoposide and platinum (either cisplatin or carboplatin) for the first-line treatment of patients with advanced LCNEC

Primary Outcome Measure

the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the 1st-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review. [ Time Frame: 12 months ]

Central Contacts

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