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

NCT04739358 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

  • Advanced Non-Small Cell Lung Cancer With MET Mutations

Interventions

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.

Sponsors & Collaborators

  • EMD Serono Research & Development Institute, Inc.

    collaborator INDUSTRY

  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • David R Camidge, MD, PhD · University of Colorado, Denver

  • Tejas Patil, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2023-06-23
Completion
2023-06-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04739358 on ClinicalTrials.gov