Please Confirm

This website is an information resource intended only for Healthcare Professionals from U.S. who are interested in information on Clinical Research and EMD Serono clinical trials. 

By clicking “I am a healthcare professional” you are declaring and confirming that you are a Healthcare Professional inside the U.S. and have read and understood this disclaimer.

I AM NOT A HEALTHCARE PROFESSIONAL

Please Confirm

This website is an information resource intended only for Healthcare Professionals from U.S. who are interested in information on Clinical Research and EMD Serono clinical trials.

By clicking "I am a healthcare professional" you are declaring and confirming that you are a Healthcare Professional inside the U.S. and have read and understood this disclaimer.

 

INSIGHT 2: Advanced/Metastatic NSCLC With MET amplification and Acquired Resistance to Osimertinib

A phase 2 clinical study of tepotinib combined with osimertinib in patients with advanced or metastatic MET-amplified non-small cell lung cancer (NSCLC) with activating changes in the EGFR gene and resistance to prior osimertinib therapy

ClinicalTrials.gov:

NCT03940703

ADVANCED
METASTATIC

PHASE 2

COMBINATION
THERAPY

NOW ENROLLING

Purpose of this study


 

In this phase 2 trial, the safety and efficacy of tepotinib, an oral and once-daily MET inhibitor, will be investigated when it is administered in combination with osimertinib in patients with MET-amplified, advanced or metastatic NSCLC harboring activating EGFR mutations with acquired resistance to prior osimertinib.

The primary outcomes of this trial are:

  • Objective response for combined therapy (by independent review)
  • Dose-limiting toxicities (safety run-in only)

This trial will also measure:

  • Objective response for combination therapy (by investigator) and for tepotinib monotherapy (by independent review and by investigator)
  • Duration of response, disease control, progression-free survival (by independent review and by investigator)
  • Overall survival 
  • Safety
  • Biomarkers and pharmacokinetics
  • Health-related quality of life

 

Contact us


 

US Medical Information: 888-275-7376 - eMediUSA@emdserono.com

Global Communication Center: +49 6151 72 5200 - service@emdgroup.com

Singapore Medical Information: +65 6890 6638 - medinfo_singapore@merckgroup.com

  

Key inclusion criteria for INSIGHT 2*


  • Histologically or cytologically confirmed, locally advanced or metastatic NSCLC with documented activating EGFR mutation
  • MET amplification determined by FISH on tissue biopsy (central or local testing) or blood-based next generation sequencing (central testing). Samples collected following progression on prior first-line osimertinib
  • Acquired resistance to prior first-line osimertinib, and first-line osimertinib as the only prior therapy for advanced/metastatic NSCLC†
  • ECOG performance status of 0 or 1
  • Age ≥18 years

Key exclusion criteria for INSIGHT 2*


  • Patients with spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention
  • Inadequate hematological, liver or renal function
  • Impaired cardiac function or hypertension uncontrolled by standard therapies
  • Any unresolved grade 2 or higher toxicity from previous anticancer therapies

 

 

INSIGHT 2 Study Design

 

 

*For a full list of all outcome measures and inclusion and exclusion criteria, please visit ClinicalTrials.gov, NCT03940703.

†Patients must have had a radiologically confirmed response or stable disease (for a least 6 months) to treatment with first-line osimertininb, followed by radiologically documented disease progression.

‡Target enrollment.

§500 mg tepotinib hydrochloride hydrate which is equivalent to 450 mg tepotinib (the free base form).

Initially, eligible patients who are detected to be positive for MET amplification will be randomly assigned in a ratio of 2:1 to either the combination of tepotinib osimertinib or tepotinib alone until 12 patients with MET amplification centrally confirmed by FISH ( TBx ) are enrolled in the monotherapy arm. After this, all patients will be assigned to the combination. Patients who are randomized to tepotinib monotherapy will have the opportunity to switch over to the combination at the time of disease progression.

Treatment continues until progression of disease, death, withdrawal of consent, or development of unacceptable toxicities.

DC, disease control; DLT, dose-limiting toxicity; DOR, duration of response; HRQoL, health-related quality of life; OR, objective response; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics.

References:

  1. 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 (NSCLC).  https://clinicaltrials.gov/ct2/show/NCT03940703. Accessed July 2, 2021.
  2. Dooms C, Nadal E, Raskin J, Demedts I, Mazieres J, Wislez M, et al. Tepotinib + osimertinib for EGFR-mutant NSCLC with resistance to first line osimertinib due to MET amplification: INSIGHT 2. Presented at: World Conference on Lung Cancer 2021; September 8-14, 2021; Virtual [abstract 167].

  

 

How do I enroll a patient in the INSIGHT 2 clinical trial?

 

Please contact us for more information on this trial, including how to enroll patients

 

US Medical Information: 888-275-7376 - eMediUSA@emdserono.com

Global Communication Center: +49 6151 72 5200 - service@emdgroup.com

Singapore Medical Information: +65 6890 6638 - medinfo_singapore@merckgroup.com

 

 

Tepotinib is being investigated in this clinical trial and is under clinical investigation in several countriesThis page describes one of the clinical trials for tepotinib, and it includes information about how the safety and efficacy of tepotinib will be measured and evaluated. The safety and efficacy of tepotinib have to be investigated following the respective local regulations and laws. There is no guarantee that tepotinib will be approved in the sought-after indication by the competent health authority in your country.

INSIGHT 2 Clinical Trial Locations

LOCATION CITY STATE POSTAL CODE COUNTRY STATUS

Learn More About

Clinical Trials