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A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50% - R2810-ONC-16113

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
2. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic/recurrent site, which has not previously been irradiate
3. Expression of PD-L1 in <50% of tumor cells determined by the commercially available assay performed by the central laboratory
4. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
6. Anticipated life expectancy of at least 3 months

Criteri di esclusione: 

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
2. Active or untreated brain metastases or spinal cord compression
3. Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs)
7. Previous treatment with idelalisib at any time (ZYDELIG®)
8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization

Trattamento sperimentale: 

Treatment Arm B: REGN2810 350 mg Q3W for 108 weeks plus standard-of-care platinum-based doublet chemotherapy for 4 to 6 cycles
Treatment Arm C: REGN2810 350 mg Q3W for 108 weeks plus ipilimumab 50 mg every 6 weeks (Q6W) for up to 4 doses

Trattamento di controllo: 

Treatment Arm A: standard-of-care platinum-based doublet chemotherapy every 3 weeks (Q3W) for 4 to 6 cycles
(followed by optional pemetrexed maintenance for those patients initially assigned to receive a pemetrexed-containing regimen)

Obiettivi primari dello studio: 

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 plus standard-of-care platinum-based doublet chemotherapy combination therapy or REGN2810 plus ipilimumab combination therapy with standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand 1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells.

Centri partecipanti

Nord Italia

A.O. Treviglio - Caravaggio
Piazzale Ospedale 1 - 20047 Treviglio - BG
U.O.C. Oncologia

Riferimento: Dr. Fausto Petrelli
Telefono: 0363424420
Email: fausto_petrelli@asst-bgovest.it

 

ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR

Riferimento: Dr. Rodolfo Passalacqua
Telefono: 0372405242
Email: r.passalcqua@asst-cremona.it

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC
S.C. Oncologia Medica

Riferimento: Dr. Angelo Delmonte

 

Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI
S.C. Oncologia Falck

Riferimento: Prof. Salvatore Siena
Telefono: 0264443624
Email: salvatore.siena@ospedaleniguarda.it

 

A.O.U. “ Maggiore della Carità”
Corso Mazzini 18 - 28100 Novara - NO
S.C.D.U Oncologia

Riferimento: Dr.ssa Gloria Borra
Telefono: 03213733984

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
Oncologia Medica - Dipartimento Emergenza-Urgenza e Area medica generale e specialistica

Riferimento: Dr. Marcello Tiseo
Email: mtiseo@ao.pr.it

 

Ospedale di Piacenza
Via Taverna 49 - 29121 Piacenza - PC
S.C. Oncologia

Riferimento: Dr. Luigi
Telefono: 0523302697
Email: l.cavanna@ausl.pc.it

 

A.O. Busto Arsizio - P.O. Saronno
Piazzale Borella 1 - 21047 Saronno - VA
S.C. Oncologia Medica

Riferimento: Dr. Claudio Verusio
Telefono: 029613576
Email: claudio.verusio@asst-valleolona.it

 

Centro Italia

AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI
Dipartimento Cardio Toraco Vascolare -U.O. Pneumologia Universitaria

Riferimento: Dr. Antonio Chella
Telefono: 050996778
Email: a.chella@ao-pisa.toscana.it

 

AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR
S.C. Oncologia

Riferimento: Dr.ssa Claudia Caserta

 

Sud Italia e isole

AOU di Cagliari - Presidio Policlinico Monserrato
St.Statale 554, Km 4500 - 09100 Monserrato - CA
UOC Oncologia Medica

Riferimento: Prof. Mario Scartozzi
Telefono: 07051093217
Email: marioscartozzi@gmail.com

 

IRCCS CROB
Via Padre Pio 1 - 85028 Rionero In Vulture - PZ
UO Oncologia Medica

Riferimento: Dr. Michele Aieta
Telefono: 0972726255
Email: michele.aieta@crob.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-001311-36

Data di inserimento: 21.08.2018

Promotore

CRO

ICON

Principal Investigator ITALIA

ASST Cremona

Riferimento: Dr. Rodolfo Passalacqua

Telefono: 0372405242

Email: r.passalcqua@asst-cremona.it

Localita: Cremona

 

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