Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393816
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-17
Brief Title:
FIRST-NEC GFPC 01-2022 - Combination of Durvalumab With Etoposide and Platinum
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
A Multicenter Phase II Study Evaluating the Efficacy and Safety of the Combination of Durvalumab With Etoposide and Platinum as First Line Treatment in Patients With Large-cell Neuroendocrine Carcinomas LCNECs of the Lung
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRST-NEC
Brief Summary:
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
Detailed Description:
Large-cell neuroendocrine carcinomas LCNECs of the lung are lung tumors 2 included with small-cell lung cancers SCLCs in the subgroup of pulmonary neuroendocrine tumors of high-grade malignancy Histopathological diagnosis of LCNEC is difficult with a confirmation rate of only 70-80 after centralized expert-pathologist review The prognosis of advanced LCNECs is poor with overall survival OS of 8-10 months
The platinum-based regimen is the current recommended first-line treatment for advanced LCNECs in analogy with that given for SCLCs The previous pivotal GFPC 03-02 trial demonstrated the efficacy of first-line platinum-etoposide in advanced LCNECs with a median Progression-Free Survival PFS OS and 1-year PFS of 5 months 77 months and 15 respectively
The GFPC 03-2017 trial has recently reported that 75 of the tumor samples of LCNEC express programmed cell death protein-ligand-1 PD-L1 in immune infiltrating tumor cells ICs and PD-L1 expression on ICs has been previously correlated with clinical efficacy of Immune Checkpoint Inhibitors ICI in Non-small Cell Lung Cancer
Numerous retrospective studies have also suggested ICI efficacy against LCNECs with significantly prolonged OS observed in ICI-treated LCNEC patients
Recently the prospective NIPINEC study results demonstrated second-line nivolumab-ipilimumab efficacy against LCNECs Moreover at ESMO 2022 the NICE-NEC prospective phase II study on LCNECs of digestive origin found an impressive efficacy of first-line triplet platinum-etoposide-ICI with a median OS of 139 months and 44 of long survivor patients OS18 months
Finally the CASPIAN trial demonstrated the superiority of the combination of durvalumab with platinum-etoposide compared to chemotherapy alone in patients with SCLCs with an acceptable toxicity profile
Therefore within the network of GFPC centers the investigators propose a prospective multicenter open-label phase II study with an external control arm ESME database that aims at evaluating the efficacy and safety of the combination of durvalumab with platinum-etoposide chemotherapy as first-line treatment in patients with an advanced LCNECs
The platinum-based regimen is the current recommended first-line treatment for advanced LCNECs in analogy with that given for SCLCs The previous pivotal GFPC 03-02 trial demonstrated the efficacy of first-line platinum-etoposide in advanced LCNECs with a median Progression-Free Survival PFS OS and 1-year PFS of 5 months 77 months and 15 respectively
The GFPC 03-2017 trial has recently reported that 75 of the tumor samples of LCNEC express programmed cell death protein-ligand-1 PD-L1 in immune infiltrating tumor cells ICs and PD-L1 expression on ICs has been previously correlated with clinical efficacy of Immune Checkpoint Inhibitors ICI in Non-small Cell Lung Cancer
Numerous retrospective studies have also suggested ICI efficacy against LCNECs with significantly prolonged OS observed in ICI-treated LCNEC patients
Recently the prospective NIPINEC study results demonstrated second-line nivolumab-ipilimumab efficacy against LCNECs Moreover at ESMO 2022 the NICE-NEC prospective phase II study on LCNECs of digestive origin found an impressive efficacy of first-line triplet platinum-etoposide-ICI with a median OS of 139 months and 44 of long survivor patients OS18 months
Finally the CASPIAN trial demonstrated the superiority of the combination of durvalumab with platinum-etoposide compared to chemotherapy alone in patients with SCLCs with an acceptable toxicity profile
Therefore within the network of GFPC centers the investigators propose a prospective multicenter open-label phase II study with an external control arm ESME database that aims at evaluating the efficacy and safety of the combination of durvalumab with platinum-etoposide chemotherapy as first-line treatment in patients with an advanced LCNECs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None