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516-005 - A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
- Receipt of at least one but not more than two prior treatment regimens in the advanced setting
- Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
- Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
- Candidate to receive docetaxel as second or third line therapy.

Criteri di esclusione: 

- Uncontrolled brain metastases
- Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
- Unacceptable toxicity with prior checkpoint inhibitor therapy
- Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
- Impaired heart function.

Schema di trattamento: 

- Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.

- Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.

Trattamento sperimentale: 

Nivolumab and Sitravatinib

Trattamento di controllo: 

Docetaxel

Obiettivi primari dello studio: 

- Overall Survival (OS) [ Time Frame: 36 Months ]
OS is defined as time from date of randomization to date of death due to any cause.

Obiettivi secondari dello studio: 

- Adverse Events (AEs) [ Time Frame: 36 Months ]
Frequency of patients experiencing treatment-emergent AEs

- Objective Response Rate (ORR) [ Time Frame: 36 Months ]
ORR defined as complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy

- Progression-Free Survival (PFS) [ Time Frame: 36 months ]
PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause.

Centri partecipanti

Nord Italia

AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL

 

ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR

 

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof. Filippo De Marinis
Telefono: 0257489773
Email: filippo.demarinis@ieo.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

 

Ospedale di Piacenza
Via Taverna 49 - 29121 Piacenza - PC
Osp. Guglielmo da Saliceto

 

Ospedale di Circolo Fondazione Macchi
Viale Luigi Borri 57 - 21100 Varese - VA

 

Centro Italia

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

 

AOU Policlinico Vittorio Emanuele PO G. Rodolico
Via S. Sofia 78 - 95123 Catania - CT

 

Presidio Ospedaliero Vito Fazzi Asl Lecce
Piazzetta F. Muratore - 73100 Lecce - LE

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-001043-41

Data di inserimento: 04.02.2022

Promotore

Mirati Therapeutics Inc.

Principal Investigator ITALIA

IEO - Istituto Europeo di Oncologia

Riferimento: Prof. Filippo De Marinis

Telefono: 0257489773

Email: filippo.demarinis@ieo.it

Localita: Milano

 

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