Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics
(PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with
the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic
non-small cell lung cancer (NSCLC).
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Thoracic Oncology
Enrollment Eligibility
Inclusion Criteria:
- 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
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- 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
- Other protocol defined exclusion criteria could apply.