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A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer - C4221008

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

- Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is currently Stage IV.
- Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay.
- Patients who are either treatment-naïve (e.g., no prior systemic therapy for advanced/metastatic disease), OR who have received 1) first-line platinum-based chemotherapy OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/ programmed cell death protein ligand 1(PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy.
- Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow function characterized by the following at screening:
    - absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
    - Platelets ≥ 100 × 10⁹/L;
    - Hemoglobin ≥ 8.5 g/dL (with or without blood transfusions).
- Adequate hepatic and renal function characterized by the following at screening:
    - Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
    - alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases; Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate > 50 mL/min/1.73m².

Criteri di esclusione: 

- Patients who have documentation of any of the following:
    - epidermal growth factor receptor (EGFR) mutation
    - anaplastic lymphoma kinase (ALK) fusion oncogene or
    - ROS1 rearrangement
- Patients who have received more than 1 prior line of systemic therapy in the advanced/metastatic setting.
- Previous treatment with any BRAF inhibitor (e.g., dabrafenib, vemurafenib, XL281/BMS-908662, etc.), or any mitogen-activated protein kinase (MEK) inhibitor (e.g., trametinib, cobimetinib, selumetinib, RDEA119, etc.) prior to screening and enrollment.
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease.
- Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phospho)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- Patients with symptomatic brain metastasis, leptomeningeal disease or other active central nervous system (CNS) metastases are not eligible.

Schema di trattamento: 

Study treatment with encorafenib and binimetinib will be self-administered orally without regard to food.

Patients will receive the following per 28-day (± 3 days) cycle:
- Encorafenib: 450 mg (6 × 75 mg capsule) once daily (QD)
- Binimetinib: 45 mg (3 × 15 mg tablet) twice daily (BID)

Trattamento sperimentale: 

Encorafenib + Binimetinib

Trattamento di controllo: 

/

Obiettivi primari dello studio: 

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: Up to 24 months ]

Obiettivi secondari dello studio: 

- Duration of Response (DOR) [ Time Frame: Up to 24 months ]
- Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
- Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
- Overall Survival (OS) [ Time Frame: Up to 24 months ]
- Incidence and severity of adverse events (AEs) [ Time Frame: Up to 24 months ]

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
NB Arruolamento pazienti non ancora attivo

Riferimento: Dr.ssa Marina Garassino
Telefono: 0223903813
Email: marina.garassino@istitutotumori.mi.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
NB Arruolamento pazienti non ancora attivo

 

Presidio Ospedaliero di Faenza
Viale Stradone 9 - 48018 Faenza - RA
NB Arruolamento pazienti non ancora attivo

 

Ospedale di Lugo
Viale Dante 10 - 48022 Lugo - RA
Ospedale Civile Umberto I - NB Arruolamento pazienti non ancora attivo

 

Ospedale S. Maria delle Croci, Ravenna
Viale Randi 5 - 48121 Ravenna - RA
NB Arruolamento pazienti non ancora attivo

 

Ospedale Cervesi
Via Beethoven 2 - 47841 Cattolica - RN
NB Arruolamento pazienti non ancora attivo

 

Ospedale “Infermi” Rimini
Via Settembrini 2 - 47923 Rimini - RN
NB Arruolamento pazienti non ancora attivo

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

Riferimento: Prof.ssa Silvia Novello
Telefono: 0119026978
Email: Silvia.novello@unito.it

 

Centro Italia

Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM
NB Arruolamento pazienti non ancora attivo

 

Sud Italia e isole

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

Riferimento: Dr. Alessandro Morabito
Telefono: 0815903631
Email: a.morabito@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-000417-37

Data di inserimento: 27.01.2021

Promotore

Pfizer

CRO

NA

Principal Investigator ITALIA

IRCCS Ospedale San Raffaele, Milano

Riferimento: Dr. Non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Milano

 

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