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

Conditions

• Advanced Non-Small Cell Lung Cancer With MET Mutations

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tepotinib — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 25, 2022

Status verified

Oct 2023

Primary completion

Jun 23, 2023

Completion

Jun 23, 2023

Study Design

Enrollment

2 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Monotherapy
  * Dose Escalation Phase for participants with MET-driven NSCLC. * Dose Expansion Phase: CNS Efficacy Dose Expansion Cohort for participants with MET-driven NSCLC and measurable CNS disease.
• Experimental: Combination Therapy
  * Dose Escalation Phase for participants with evidence of MET-driven acquired -resistance. * Dose Expansion Phase for participants with evidence of MET-driven acquired -resistance with or without measurable CNS disease.

Primary Outcome Measure

ARM 1 (Monotherapy) Dose Limiting Toxicity (DLT) [ Time Frame: 1 year ]

Locations (5)

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