EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutat… (NCT03516214) | Clinical Trial Compass
CompletedPhase 1
EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations
Germany18 participantsStarted 2018-04-25
Plain-language summary
The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating mutations in the epithelial growth factor receptor (EGFR).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Written informed consent must have been obtained prior to any screening procedures.
✓. Patients (male or female) ≥ 18 years of age.
✓. Histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
✓. Presence of at least one measurable lesion according to RECIST v.1.1.
✓. ECOG performance status ≤ 2
✓. Patients must have NSCLC harbouring EGFR p.L858R or EGFR del19 as assessed by local testing.
✓. Patients must be EGFR TKI treatment naïve (prior chemotherapy treatment is allowed) or must have progressed while on continuous treatment with a first- or second-generation EGFR TKI (EGFR p.T790M-negative or -positive) or must have progressed while on continuous treatment with osimertinib (EGFR p.T790M-negative or -positive)
✓. In patients who have received no prior EGFR TKI treatment, an archival biopsy sample, defined as a sample being obtained prior to any anti-cancer treatment is mandatory. If an archival biopsy fulfilling this criterion is not available, patients must be suitable and willing to undergo baseline biopsy according to the local institution's guidelines (newly obtained biopsy).
Exclusion criteria
✕. History of allergic reactions or hypersensitivity to one of the study drugs or to any component of the study drugs
✕. Prior treatment with any investigational agent known to inhibit EGFR (mutant or wild-type)
What they're measuring
1
Incidence of dose-limiting-toxicities (DLT) of the combination of EGF816 and trametinib to assess the maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
Timeframe: Approximately one and a half years (from FPFV until the end of the DLT period of the last patient included into the trial or until death of the last patient, whichever occurs first)
✕. Prior treatment with any agent known to inhibit MEK/ERK or other mediators of RAS pathway.
✕. Patients with high level MET amplification in the archival or newly obtained biopsy sample as determined by local testing. High-level MET amplification is defined as: a) a MET/CEN7 ratio ≥2.0 and/or b) an average MET gene copy number per cell of ≥6.0 \[modified Schildhaus et al., 2015\].
✕. Patients with EGFR mutations other than EGFR del19, p.L858R or p.T790M.
✕. Patients with brain metastases. However, if radiation therapy and/or surgery has been completed at least 4 weeks prior to screening for the trial and evaluation by CT (with contrast enhancement) or MRI at study baseline demonstrates the disease to be stable and if the patient remains asymptomatic and off steroids, then patients with brain metastases may be enrolled.
✕. Patients with presence or history of carcinomatous meningitis.
✕. Any acute or chronic medical, mental or psychological condition, which in the opinion of the investigator would not permit the patient to participate or complete the study or understand the patient information