Efficacy and Safety Study of a New Therapeutic Strategy in the Treatment of Extended-Disease Small-Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

June 1, 2023

Study Completion Date

June 19, 2024

Conditions
Small Cell Lung Cancer
Interventions
DRUG

Etoposide

Induction phase: 100 mg/sqm on days 1-3, for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Treatment will continue until progression of disease, unacceptable toxicity, patient refusal.

DRUG

Carboplatin

Induction phase: AUC 5 on day 1 for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Treatment will continue until progression of disease, unacceptable toxicity, patient refusal.

DRUG

Bevacizumab

"Induction phase: 7.5 mg/kg on day 1, for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration.~Maintenance phase: 7.5 mg/kg on day 1, for a maximum of 12 cycles (each one of 21 days duration). Intravenous administration.~In both phases, the treatment will continue until progression of disease, unacceptable toxicity, patient refusal."

DRUG

Atezolizumab

"Induction phase: flat dosing of 1200 mg on day 1, for a maximum of 6 cycles ( each one of 21 days duration). Intravenous administration.~Maintenance phase: flat dosing of 1200 mg on day 1, for a maximum of 12 cycles (each one of 21 days duration). Intravenous administration.~In both phases, the treatment will continue until progression of disease, unacceptable toxicity, patient refusal, loss of clinical benefit."

Trial Locations (14)

12100

UOC Oncologia Medica - AO S. Croce e Carle di Cuneo, Cuneo

16132

Oncologia medica - Policlinico San Martino, Genova

26100

UO di Oncologia - Istituti Ospitalieri di Cremona - ASST Di Cremona, Cremona

33100

Dipartimento di Oncologia ASUIUD, Udine

35128

Istituto Oncologico Veneto IRCCS, Padua

37045

UOC Oncologia Medica - Azienda ULSS9 Veneto, Legnago

40138

UOC di Oncologia Medica - AOU Policlinico S. Orsola Malpighi, Bologna

41012

UOC Medicina Oncologica - Ospedale di Carpi - Azienda USL di Modena, Carpi

41124

Dip. Oncologia-Ematologia - UO Oncologia - AOU Policlinico di Modena, Modena

43126

UOC di Oncologia Medica - AOU di Parma, Parma

44124

UOC di Oncologia Ematologia - AOU di Ferrara, Ferrara

50134

UOC Oncologia Medica 1 - AOU Careggi, Florence

72100

UOC Oncologia Medica - PO A.Perino - ASL di Brindisi, Brindisi

80131

"UOC Oncologia Medica - AORN A. Cardarelli", Napoli

All Listed Sponsors
collaborator

Roche Pharma, Italy

UNKNOWN

collaborator

YGHEA, CRO Division of Ecol Studio spa

INDUSTRY

collaborator

Dr. Luca Boni U.O. Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino - IST NORD CBA

UNKNOWN

lead

Gruppo Oncologico Italiano di Ricerca Clinica

OTHER

NCT04730999 - Efficacy and Safety Study of a New Therapeutic Strategy in the Treatment of Extended-Disease Small-Cell Lung Cancer | Biotech Hunter | Biotech Hunter