CompletedPhase 1

EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

Germany, Spain18 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 range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT03516214

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Bronchial Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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)

EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria