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A study of tepotinib plus osimertinib in epidermal growth factor receptor (EGFR ) tyrosine kinase inhibitor (TKI) relapsed mesenchymal-epithelial transition factor (MET) amplified non-small cell lung cancer (INSIGHT2

Description

This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the MET inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic NSCLC.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial is to confirm a safe and tolerable recommended phase II dose (RP2D) of tepotinib when used in combination with osimertinib.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet the following criteria:

  • Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating mutation of the Epidermal Growth Factor Receptor (EGFR) receptor including T790 mutation status
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks
  • Acquired resistance on previous EGFR-Tyrosine Kinase Inhibitors (EGFR-TKI) therapy
  • MET amplification
  • Other protocol defined inclusion criteria could apply.

Excluding patients who meet the following 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
     

Accepting new patients

 

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