Trial intelligence / Profile preview

Tesevatinib in EGFR-Mutated NSCLC with CNS Metastases

NCT02616393Phase 2

Key facts

Status: Completed
Start: Nov 2015
Primary completion: Apr 2018
Countries: 1
Sponsor: Kadmon
Modality: Small Molecules

Drugs: tesevatinib
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label trial of tesevatinib in non-small cell lung cancer (NSCLC) (3 cohorts), sponsored by Kadmon. Primary endpoint: Best Overall Response Rate up to 2 years. Started Nov 2015; status: completed.

Design

3 arms

Study design: Non-randomizedOpen-label

Cohort A: Brain Metastases (BM)
Progressed with BM
Cohort B: Leptomeningeal Metastases (LM)
Progressed with LM
Cohort C: Brain Metastases at Initial Presentation (BM-IP)
Initial presentation with BM

Who it enrols

Patients with EGFR-mutated NSCLC and brain or leptomeningeal metastases, either treatment-naive (Cohort C) or progressed on prior TKI (Cohorts A/B).

Endpoints

Primary

Best Overall Response Rateup to 2 years

Secondary

Median Progression-free Survivalup to 2 years
Probability of PFS24 weeks
Probability of Overall Survival24 weeks
Median Time to Progressionup to 2 years
Probability of Time to Progression24 weeks
Quality of Life (EORTC-QLQ-C30)up to 2 years
Quality of Life (EORTC-QLQ-BN20)up to 2 years

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