Actively Recruiting
Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)
Led by Gruppo Oncologico Italiano di Ricerca Clinica · Updated on 2024-05-16
49
Participants Needed
15
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC)
CONDITIONS
Official Title
Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Age 18 years or older at study entry
- Histologically or cytologically confirmed pulmonary large-cell neuroendocrine carcinoma (LCNEC)
- Stage IV disease or unresectable stage IIIB not safely covered by a single radiotherapy field
- Body weight over 30 kg
- No prior chemotherapy or systemic anti-cancer treatment; prior chemoradiotherapy allowed if at least 6 months since last treatment and no significant toxicity remains
- No need for concurrent chest radiation
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion outside the central nervous system suitable for repeated scans
- Adequate blood counts including neutrophils, hemoglobin, and platelets
- Adequate liver and kidney function within specified limits
- Adequate coagulation function; stable anticoagulation allowed under conditions
- Female patients of childbearing potential must have a negative pregnancy test and agree to effective contraception during and after treatment
- Male patients who are sexually active must agree to use barrier contraception during and after treatment
- Ability to comply with the study protocol as judged by the investigator
You will not qualify if you...
- Symptomatic brain metastases or spinal cord compression requiring immediate radiotherapy
- History of leptomeningeal disease
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Active infections including tuberculosis, hepatitis B (active), or hepatitis C with detectable virus
- Recent significant injury, radiotherapy, or major surgery within defined timeframes
- Other malignancies within 5 years except certain treated cancers
- Prior allogeneic stem cell or solid organ transplant
- Active serious infections or uncontrolled medical conditions
- Concurrent cancer treatments other than study therapy
- Treatment with other investigational agents within 30 days
- Autoimmune or inflammatory disorders with exceptions for certain stable conditions
- History or active autoimmune neurologic paraneoplastic syndromes
- Live-virus vaccination within 30 days before treatment
- History of idiopathic pulmonary fibrosis or active pneumonitis
- Prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents
- Recent systemic immunostimulatory agents use
- Systemic corticosteroids or immunosuppressives within 14 days with exceptions
- Allergies to study drugs or their components
- Pregnant or breastfeeding patients
- Unresolved grade 2 or higher toxicity from prior cancer treatments
- Grade 2 or higher neuropathy unless approved by study physician
- Patients unwilling to use effective contraception or donate sperm/blood as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
IRCCS AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, Italy, 40138
Actively Recruiting
2
Istituto Oncologico del Mediterraneo IOM - Viagrande Catania
Viagrande, CT, Italy, 95029
Not Yet Recruiting
3
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. IRCCS
Meldola, FC, Italy, 47014
Not Yet Recruiting
4
Azienda Ospedaliera Universitaria Careggi
Florence, FI, Italy, 50134
Not Yet Recruiting
5
Humanitas Research Hospital
Rozzano, MI, Italy, 20089
Not Yet Recruiting
6
Istituto Oncologico Veneto IRCCS-IOV
Padova, PD, Italy, 35128
Not Yet Recruiting
7
Centro di riferimento oncologico di Aviano
Aviano, PN, Italy, 33081
Not Yet Recruiting
8
Azienda Ospedaliera San Camillo Forlanini-Ospedale San Camillo
Roma, RM, Italy, 00152
Not Yet Recruiting
9
AOU Sassari - Ospedale SS. Annunziata
Sassari, SS, Italy, 07100
Not Yet Recruiting
10
AOU Ospedale San Luigi Gonzaga
Orbassano, TO, Italy, 10043
Actively Recruiting
11
Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari
Bari, Italy, 70120
Not Yet Recruiting
12
Azienda Usl Toscana nord ovest Ospedale San Luca
Lucca, Italy, 55100
Not Yet Recruiting
13
Ospedale San Gerardo Monza
Monza, Italy, 20900
Actively Recruiting
14
A.O.R.N. "A. Cardarelli"
Naples, Italy, 80131
Not Yet Recruiting
15
Azienda Ospedaliera Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
Research Team
D
Davide Campana
CONTACT
M
Michele Tognetto
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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