Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono Research & Development Institute, Inc.
With
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks
Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria:
Radiological documentation of disease progression on first-line osimertinib
Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (\>) 6 months after initiation of osimertinib
Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting
MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening
Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing
Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment
You may not be if
Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention
Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia
Inadequate hematological, liver and renal function
Impaired cardiac function
History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment
Hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 millimeter of mercury (mmHg)
Contraindication to the administration of osimertinib
Clareo Health | A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
