NCT04739358

CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC

A Phase 1/2 Open-Label Study To Determine a Central Nervous System (CNS) Dose and Schedule Of Tepotinib Alone Or In Combination With Other Relevant Tyrosine Kinase Inhibitors (TKIs) In Adult Participants With MET-Driven NSCLC

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Criterium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer with central nervous system metastasis. In some patients, who have developed resistance to their tyrosine kinase inhibitors (TKIs), this study will look at how effective tepotinib is in combination with TKIs. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life.

Detailed description

Phase I - Two arms (Monotherapy and Combination therapy) with primary endpoints of Dose Limiting Toxicity Phase II - Two arms Monotherapy Cohort: Primary endpoint is Intracranial Objective Response Rate Combination Cohort: Primary endpoint is overall and extracranial Objective Response Rate among patients treated with the combination of tepotinib and concurrent TKI.

Conditions

• Advanced Non-Small Cell Lung Cancer With MET Mutations

Interventions

Type	Name	Description
DRUG	Tepotinib	Subjects will receive tepotinib daily in cycles of 21-day duration. Subjects in the Combination Therapy arm will continue to receive their last tolerable dose of tyrosine kinase inhibitor (TKI) together with tepotinib.

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2021-02-04
• Last updated: 2023-10-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study