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A phase Ib, open label, multi-center study to characterize the safety, tolerability and preliminary efficacy of EGF816 in combination with selected targeted agents in EGFR-mutant (Epidermal growth factor receptor- mutant) NSCLC (Non-small cell lung Cancer) - CEGF816X2102

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I, I B

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.
● Requirements of EGFR mutation status and prior lines of treatment:
● Treatment naive patients, who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation (e.g., L858R and/or ex19del), have not received any systemic antineoplastic therapy for advanced NSCLC and are eligible to receive EGFR TKI treatment.
Patients with EGFR exon 20 insertion/duplication are not eligible. Note: patients who have received only one cycle of chemotherapy in the advanced setting are allowed.
● Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation AND an acquired T790M mutation (e.g., L858R and/or ex19del, T790M+) following progression on prior treatment with a 1st-generation EGFR TKI or 2nd-generation EGFR TKI.
These patients may not have received more than 4 prior lines of antineoplastic therapy in the advanced setting, including EGFR TKI, and may not have received any agent targeting EGFR T790M mutation (i.e., 3rd-generation EGFR TKI).
● Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation and a “de novo” T790M mutation (i.e., no prior treatment with any agent known to inhibit EGFR including EGFR TKI). These patients may not have received more than 3 prior lines of antineoplastic therapy in the advanced setting, and may not have received any prior 3rd generation EGFR TKI.
● Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patients must be willing to undergo a new tumor biopsy during therapy on this study, and at screening if an archival tumor sample obtained since the diagnosis of advanced disease (1L patients) or since last treatment failure (2L+ patients) is not available.

Criteri di esclusione: 

● Patients with a history or presence of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
● Patients with unstable brain metastases.
● Patients with a history of another malignancy.
● Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
● Patients with clinically significant, uncontrolled heart disease.
● Patients participating in additional parallel investigational drug or medical device studies.
● Prior therapies
● Patients who have been treated with EGFR TKI in the adjuvant setting within 6 months, unless acquired EGFR T790M is present in a tumor or blood sample obtained since the discontinuation of the EGFR TKI.
● Patients who have been treated with prior EGFR TKI targeting T790M (3rd generation).
● Patients who have been treated with systemic anti-neoplastic therapy within:
● ≤ 2 weeks for fluoropyrimidine monotherapy
● ≤6 weeks for nitrosoureas and mitomycin
● ≤4 weeks or ≤ 5 half-lives (whichever is shorter) for biological therapy (including monoclonal antibodies) and continuous or intermittent small molecule therapeutics or any other investigational agent

Trattamento sperimentale: 

Dose scalation phase: EGF816 + ribociclib, trametinib, or LXH254
Dose expansion phase: EGF816 + ribociclib, trametinib, LXH254, INC280, or gefitinib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

In patients with advanced EGFR-mutant NSCLC in 1st line or ≥ 2nd line T790M+, 3rd generation EGFR TKI-naïve:
● To characterize the safety and tolerability of EGF816 in combination with ribociclib, trametinib, or LXH254, and identify their recommended dose and regimen.
● To estimate the preliminary anti-tumor activity of the addition of ribociclib, trametinib, LXH254, gefitinib, or INC280 to EGF816

Obiettivi secondari dello studio: 

To assess the preliminary anti-tumor activity of EGF816 single agent given for 5 cycles followed by the addition of ribociclib, trametinib, LXH254, gefitinib, or INC280 to EGF816 in advanced EGFR-mutant NSCLC in 1st line or ≥ 2nd line T790M+, 3rd generation EGFR TKInaive (endpoints overall response rate (ORR) , progression-free survival (PFS) , duration of
response (DOR), disease control rate (DCR).
To characterize the PK properties of EGF816 as a single agent and in combination with: ribociclib, trametinib, LXH254, gefitinib, and INC280.

Centri partecipanti

Nord Italia

Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI

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

 

Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN

Riferimento: Prof.ssa Rossana Berardi
Telefono: 0715965715
Email: r.berardi@univpm.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-002496-25

Data di inserimento: 08.11.2018

Promotore

Novartis

CRO

OPIS srl

Principal Investigator ITALIA

Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi di Ancona

Riferimento: Prof.ssa Rossana Berardi

Telefono: 0715965715

Email: r.berardi@univpm.it

Localita: Ancona

 

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