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

Running, not enrolling · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

This study was to 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).

Key facts

Study ID

NCT03940703

Run by

EMD Serono Research & Development Institute, Inc.

People needed

140

Starts

2019-09-19

Expected to finish

2026-12-31

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• Other protocol defined inclusion criteria could apply

You may not qualify 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
• Other protocol defined exclusion criteria could apply.

Where it is running

• Compassionate Care Research Group Inc - Edinger Medical Group, Inc. — Fountain Valley, California, United States
• Memorial Care — Long Beach, California, United States
• Ventura County Hematology Oncology Specialists — Oxnard, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Eastern Connecticut Hematology & Oncology Associates — Norwich, Connecticut, United States
• Holy Cross — Fort Lauderdale, Florida, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Ocala Oncology — Ocala, Florida, United States
• University Cancer and Blood Center — Athens, Georgia, United States
• Hawaii Cancer Care — Honolulu, Hawaii, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Community Health Network — Indianapolis, Indiana, United States
• Beacon Health — South Bend, Indiana, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Pontchartrain — Hammond, Louisiana, United States
• Medstar Franklin Square Clinical Research Center — Baltimore, Maryland, United States
• The Center for Cancer & Blood Disorders - Maryland — Bethesda, Maryland, United States
• Frederick Health- James M Stockman Cancer Institute — Frederick, Maryland, United States
• Boston Medical Center - Dept. Hematology/Oncology — Boston, Massachusetts, United States
• Southcoast Center for Cancer Care — Fairhaven, Massachusetts, United States
• Sparrow Hospital Herbert - Herman Cancer Center — Lansing, Michigan, United States
• Central Care Cancer Center (CCCC) — Bolivar, Missouri, United States
• Yuma Regional Medical Center — Yuma, Arizona, United States

Full record on ClinicalTrials.gov

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