Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 27, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Pulmonary Large-cell Neuroendocrine Carcinoma
Interventions
DRUG

Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI]

"Intravenous infusion of durvalumab 1500 mg on day 1 (induction phase) with carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3) every 3 weeks, and durvalumab (1500 mg on day 1) administered every three weeks for up to 4 cycles (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit (for durvalumab).~Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks ± 3 days (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit."

Trial Locations (15)

10043

RECRUITING

AOU Ospedale San Luigi Gonzaga, Orbassano

20089

NOT_YET_RECRUITING

Humanitas Research Hospital, Rozzano

20900

RECRUITING

Ospedale San Gerardo Monza, Monza

33081

NOT_YET_RECRUITING

Centro di riferimento oncologico di Aviano, Aviano

35128

NOT_YET_RECRUITING

Istituto Oncologico Veneto IRCCS-IOV, Padua

40138

RECRUITING

IRCCS AOU Policlinico Sant'Orsola Malpighi, Bologna

43126

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria di Parma, Parma

47014

NOT_YET_RECRUITING

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l. IRCCS", Meldola

50134

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Careggi, Florence

55100

NOT_YET_RECRUITING

Azienda Usl Toscana nord ovest Ospedale San Luca, Lucca

70120

NOT_YET_RECRUITING

Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari, Bari

80131

NOT_YET_RECRUITING

"A.O.R.N. A. Cardarelli", Napoli

95029

NOT_YET_RECRUITING

Istituto Oncologico del Mediterraneo IOM - Viagrande Catania, Viagrande

00152

NOT_YET_RECRUITING

Azienda Ospedaliera San Camillo Forlanini-Ospedale San Camillo, Roma

07100

NOT_YET_RECRUITING

AOU Sassari - Ospedale SS. Annunziata, Sassari

All Listed Sponsors
lead

Gruppo Oncologico Italiano di Ricerca Clinica

OTHER