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SPI-POZ-202: Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

NCT03318939 | NCT03318939

Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Associated Conditions

Lung Cancer

Principal Investigator

Sponsor

Spectrum Pharmaceuticals, Inc.

Trial Type: Treatment.

This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in four patient cohorts for up to 174 previously treated NSCLC patients with any systemic therapy (Cohort 1: 87 patients with EGFR exon 20 insertion mutations, Cohort 2: 87 patients with HER2 exon 20 insertion mutations), up to 140 treatment-naive NSCLC patients (Cohort 3: 70 patients with EGFR exon 20 insertion mutations, Cohort 4: 70 patients with HER2 exon 20 insertion mutations). For Amendment 2, approximately 180 patients in Cohort 5 (60 patients per dose group), 30 patients in Cohort 6, and 30 patients in Cohort 7 are being added.

This study is currently enrolling.