CompletedPhase 1/2

A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

United States, Canada, Germany225 participantsStarted 2014-06-06

Plain-language summary

This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase). The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: (For all patients unless otherwise specified) * Histologically or cytologically confirmed locally advanced (stage IIIB not amenable to definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC. * Patients with controlled brain metastases * ECOG performance status: Phase I part: 0, 1, or 2; Phase II part: 0 or 1 * Presence of at least one measurable lesion according to RECIST 1.1 per investigator assessment * Patients who are either Hepatitis B surface antigen (HBsAg) positive or hepatitis B virus (HBV)-DNA positive must be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816 * Patients must have negative hepatitis C antibody (HCV-Ab) or positive HCV-Ab but undetectable level of HCV-RNA. Note: patients with detectable HCV-RNA are not eligible for the study. * For Phase I: patients must have failed no more than 3 lines of any systemic antineoplastic therapy for advanced NSCLC, including EGFR-TKI * For Phase II: patients must be naïve from any systemic antineoplastic therapy in the advanced setting. Patients who have failed no more than 1 cycle of systemic antineoplastic therapy in the advanced setting are allowed. Exclusion criteria: (For all patients unless otherwise specified) * Patients with a history or presence of interstitial lung disease (ILD) or interstitial pneumonitis, including clinical…

What they're measuring

Number of Participants With Dose Limiting Toxicities (DLTs) (Phase I Part)

Timeframe: First 28 days of dosing

Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) (Phase II Part)

Timeframe: From baseline up to 64 weeks

Trial details

NCT IDNCT02108964

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-22

Results submitted2020-10-01