A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    120
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 12 September 2021
Investigator
US Medical Information
Primary Contact
CHU de Toulouse - H pital Larrey - Service de Pneumologie et Oncologie Pneumologique (0.0 mi away) Contact
+182 other location
growth factor
epidermal growth factor receptor
EGFR
epidermal growth factor
stage iv non-small cell lung cancer
osimertinib
lung carcinoma

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).

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Osimertinib, tepotinib
Clinical Study IdentifierNCT03940703
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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
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