A phase I/II, multicenter, open-label study of EGFRmut-TKI EGF816, administered orally in adult patients with EGFRmut solid malignancies (CEGF816X2101)
- Conditions
- non-small cell lung cancerlung cancer1003866610029107
- Registration Number
- NL-OMON52991
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
• Female and male patients >= 18 years of age.
• Stage IIIB/IV EGFR mutant NSCLC, histologically or cytologically confirmed.
• Patients with controlled brain metastases may participate in the trial. See
protocol page 14 for details.
• Measurable disease.
• ECOG performance status 0, 1.
• HBV under control and HCV negative., Specific criteria groups 1-6 (see also
protocol page 14-15) for phase I and II:
Group 1:
• EGFR activating mutation (e.g., L858R and/or ex19del)
• no systemic antineoplastic therapy for advanced NSCLC (no more than 1 cycle
of chemotherapy in the advanced setting is allowed)
Group 2:
• EGFR activating mutation (e.g., L858R and/or ex19del) and
• acquired EGFR T790M mutation
• progressed on 1 and only 1 prior treatment with a 1st-generation EGFR TKI or
2nd-generation EGFR TKI
• no more than 3 prior lines of systemic antineoplastic therapies in the
advanced setting
• EGFR TKI treatment must be the last prior treatment before study entry
Group 3:
• *de novo* EGFR T790M mutation (see protocol page 14-15)
• no more than 3 prior lines of systemic antineoplastic therapies in the
advanced setting
• no prior treatment with any therapy known to inhibit EGFR
Group 4:
• EGFR exon 20 insertion or deletion
• no more than 3 prior lines of systemic antineoplastic therapies in the
advanced setting
Group 5:
• EGFR activating mutation (e.g., L858R and/or ex19del) and
• without an acquired EGFR T790M mutation
• progressed on 1 and only 1 prior treatment with a 1st-generation EGFR TKI or
2nd-generation EGFR TKI
• no more than 3 prior lines of systemic antineoplastic therapiesin the
advanced setting
• EGFR TKI treatment must be the last prior treatment before study entry
Group 6:
• EGFR activating mutations (e.g., L858R or ex19del) and
• an acquired T790M mutation
• had treatment with a 1st/2ndgeneration EGFR TKI
• progressed on or are intolerant to a 3rd-generation EGFR TKI
• no more than 3 prior lines of systemic antineoplastic therapies in the
advanced setting
• 3rd-generation EGFR TKI treatment must be the last prior treatment before
study entry
• Interstitial pneumonitis or interstitial lung disease.
• History of malignicity last 3 year
• Strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued 1 week
prior to the start of EGF816.
• Pregnancy, lactation, inadequate contraception (males and females).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I: MTD or RP2D<br /><br>Phase II: ORR.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Phase I:<br /><br>Adverse events, ORR, DOR, DCR, PFS, TTR and PK characteristics of EGF816 and<br /><br>metabolite LMI258. Determination of EGFR pathway induction.<br /><br><br /><br>Phase II:<br /><br>Adverse events, ORR, DOR, DCR, PFS, TTR and OS PK characteristics of EGF816 and<br /><br>metabolite LMI258.</p><br>