NCT03823625 - An Open-label, Randomized, Parallel, Non Comparative, Phase II Trial of Nivolumab Plus Ipilimumab Versus Platinum-based Chemotherapy Plus Nivolumab in Chemonaive Metastatic or Recurrent Squamous-Cell Lung Cancer (SqLC) | Biotech Hunter

Enrollment

112

Participants

Timeline

Start Date

September 13, 2017

Primary Completion Date

February 28, 2021

Study Completion Date

February 28, 2021

Conditions

Squamous-Cell Lung Cancer

Interventions

DRUG

Nivolumab plus Ipilimumab

Nivolumab will be administered at the standard dose of 360 mg every 3 weeks. Ipilimumab will be administered at the dose of 1 mg/kg every 6 weeks.

DRUG

Platinum-based chemotherapy plus Nivolumab

"Nivolumab will be administered at the standard dose of 360 mg every 3 weeks.~Platinum-based chemotherapy will be chosen by the investigator among the following regimens:~* Cisplatin 80 mg/mq iv day 1 and Gemcitabine 1250 mg/mq iv days 1 and 8 every 21 days;~* Carboplatin AUC 5 iv day 1 and Gemcitabine 1000 mg/mq iv days 1 and 8 iv every 21 days;~* Carboplatin AUC 6 iv day 1 and paclitaxel 200 mg/mq iv day 1 every 21 days."

Trial Locations (18)

16132

NOT_YET_RECRUITING

IRCCS A.O.U. San Martino- IST- Istituto Nazionale per la Ricerca sul Cancro- U.O.S. Tumori Polmonari, Genova

20141

RECRUITING

Istituto Europeo di Oncologia - Divisione di Oncologia Toracica, Milan

35128

RECRUITING

I.R.C.C.S. Istituto Oncologico Veneto, Padua

37024

RECRUITING

Sacro Cuore- Don Calabria Hospital- U.O.C. Oncologia Medica, Negrar

37134

ACTIVE_NOT_RECRUITING

Policlinico 'G.B.Rossi' Borgo Roma - A.O.U. Integrata (Giampaolo Tortora)- Oncologia Medica, Verona

41124

RECRUITING

A.O.U. Policlinico di Modena- Oncologia Ematologia e Malattie Apparato Respiratorio, Modena

42123

RECRUITING

IRCCS Arcispedale Santa Maria Nuova, Reggio Emilia

47014

RECRUITING

IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica, Meldola

47900

RECRUITING

"Ospedale Infermi Rimini", Rimini

48121

RECRUITING

Ospedale di Ravenna- Oncologia Medica, Ravenna

52100

NOT_YET_RECRUITING

Istituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8, Arezzo

80131

ACTIVE_NOT_RECRUITING

A.O.R.N dei Colli - Ospedale Monaldi, Napoli

85028

NOT_YET_RECRUITING

Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture

90127

ACTIVE_NOT_RECRUITING

Azienda Ospedaliera Universitaria Paolo Giaccone, Palermo

90146

NOT_YET_RECRUITING

Casa di Cura La Maddalena- U.O. Oncologia medica, Palermo

06132

RECRUITING

Azienda Ospedaliera di Perugia- S.C. Oncologia Medica, Perugia

00152

ACTIVE_NOT_RECRUITING

Azienda Ospedaliera San Camillo-Forlanini, Roma

NOT_YET_RECRUITING

"Policlinico Universitario Campus Biomedico di Roma", Roma