Actively Recruiting
FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum
Led by Centre Leon Berard · Updated on 2024-08-02
80
Participants Needed
31
Research Sites
272 weeks
Total Duration
On this page
Sponsors
C
Centre Leon Berard
Lead Sponsor
G
Groupe Francais De Pneumo-Cancerologie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at study entry
- Confirmed histological diagnosis of large-cell neuroendocrine carcinoma of the lung
- Sufficient tumor material available for central confirmation and analyses
- Locally advanced (Stage III) disease not eligible for local therapy or metastatic (Stage IV) requiring first-line treatment
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Body weight over 30 kg
- Life expectancy of at least 12 weeks
- Adequate organ and marrow function as specified (including blood counts and liver function)
- Female patients must be post-menopausal or have a negative pregnancy test if pre-menopausal
- Use of highly effective contraception during treatment and for specified periods after
- Willingness and ability to comply with study protocol and visits
- Affiliation to a social security system
- Ability to provide signed informed consent
You will not qualify if you...
- Participation in another interventional clinical study or recent enrollment without washout
- Previous treatment for metastatic LCNEC
- Prior use of PD-1 or PD-L1 inhibitors including durvalumab
- Concurrent chemotherapy, investigational, biologic, or hormonal cancer therapies (except certain hormonal therapies)
- Major surgery within 21 days before first study drug dose (except local palliative surgery or radiotherapy)
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders with specified exceptions
- Uncontrolled illnesses or conditions that may interfere with study compliance
- History of other malignancies with specific exceptions
- Central nervous system metastases unless stable and asymptomatic
- Carcinomatous meningitis
- QTcF interval 470 ms or longer
- Active primary immunodeficiency
- Active hepatitis or certain viral infections as specified
- Positive HIV or active tuberculosis infection
- Recent use of immunosuppressive medications with exceptions
- Receipt of live attenuated vaccine within 30 days before first dose
- Known allergy to study drugs or excipients
- Pregnancy or breastfeeding woman
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, France, 13616
Active, Not Recruiting
2
Chu Amiens Picardie Site Sud
Amiens, France, 80054
Not Yet Recruiting
3
Chu Angers
Angers, France, 49933
Not Yet Recruiting
4
CENTRE HOSPITALIER d'AVIGNON
Avignon, France, 84000
Not Yet Recruiting
5
CHU BREST Cavale Blanche
Brest, France, 29200
Not Yet Recruiting
6
Centre Francois Baclesse
Caen, France, 14076
Not Yet Recruiting
7
Chu Gabriel Montpied
Clermont-Ferrand, France, 63000
Not Yet Recruiting
8
Centre Hospitalier Intercommunal de Creteil
Créteil, France, 94000
Not Yet Recruiting
9
Chu Annecy Genevois
Épagny, France, 74370
Active, Not Recruiting
10
Chu Grenoble Alpes
Grenoble, France, 38043
Actively Recruiting
11
Centre Oscar Lambret
Lille, France, 59020
Not Yet Recruiting
12
Chu Dupuytren
Limoges, France, 87042
Actively Recruiting
13
Groupe Hospitalier Bretagne Sud
Lorient, France, 56100
Not Yet Recruiting
14
Centre Leon Berard
Lyon, France, 69008
Active, Not Recruiting
15
APHM, hôpital nord
Marseille, France, 13915
Active, Not Recruiting
16
Grand Hopital de L'Est Francilien - Site de Meaux
Meaux, France, 77100
Active, Not Recruiting
17
GHRMSA, hôpital Emile Muller
Mulhouse, France, 68100
Active, Not Recruiting
18
CHU NICE
Nice, France, 06001
Not Yet Recruiting
19
Hopital Cochin
Paris, France, 75014
Not Yet Recruiting
20
Hopital Tenon
Paris, France, 75020
Not Yet Recruiting
21
Centre Francois Magendie
Pessac, France, 33604
Not Yet Recruiting
22
Hospices Civils de Lyon - Lyon Sud Hospital
Pierre-Bénite, France, 69495
Active, Not Recruiting
23
Centre Hospitalier de Cornouaille
Quimper, France, 29107
Not Yet Recruiting
24
CHU Rennes
Rennes, France, 35000
Not Yet Recruiting
25
Institut de Cancerologie Strasbourg Europe
Strasbourg, France, 67033
Not Yet Recruiting
26
Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil
Strasbourg, France, 67091
Not Yet Recruiting
27
Hopital Foch
Suresnes, France, 92150
Not Yet Recruiting
28
Hia Saint Anne
Toulon, France, 83800
Not Yet Recruiting
29
Chu Toulouse
Toulouse, France, 31059
Not Yet Recruiting
30
Hopital Nord Ouest de Villefranche Sur Saone
Villefranche-sur-Saône, France, 69655
Active, Not Recruiting
31
Chu Reunion
Réunion, Reunion, 97400
Not Yet Recruiting
Research Team
J
Julien GAUTIER
CONTACT
L
Luc ODIER, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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