This phase II trial studies how well poziotinib works in treating patients with non-small lung cancer with an EGFR or HER2 exon 20 mutation that is stage IV or has come back (recurrent). Poziotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth..
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed stage IV or recurrent solid tumor not amenable to curative intent therapy
* Cohort 1 specific inclusion criteria: NSCLC with documented EGFR exon 20 mutation by one of the following Clinical Laboratory Improvement Act (CLIA) certified tests: OncoMine Comprehensive Assay (OCA), Guardant360 Assay (using plasma), or FoundationOne Assay or by a Food and Drug Administration (FDA) approved device using cobas EGFR mutation test version (v)2 or therascreen EGFR RGQ PCt kit; Mutations include D770\_N771insSVD, D770\_N771insNPG, V769\_D770insASV, H773\_V774insNPH, or any other exon 20 in-frame insertion or point mutation excluding T790M
* Cohort 2 specific inclusion criteria: NSCLC with documented HER2 exon 20 mutation by a CLIA certified tests: Oncomine Comprehensive Assay (OCA), Guardant360 Assay (using plasma), or FoundationOne Assay; eligible mutations include A775\_G776insYVMA, G776\_V777insVC, or P780\_Y781insGSP, or any other in-frame exon 20 insertion mutation or point mutation including, but not limited to, L755S, G776V, and V777L
* Cohort 3 specific inclusion criteria: NSCLC with documented EGFR exon 20 mutation (excluding T790M) by one of the following CLIA certified tests: OncoMine Comprehensive Assay (OCA), Guardant360 Assay (using plasma), or FoundationOne Assay or by an FDA approved device using cobas EGFR mutation test v2 or therascreen EGFR RGQ PCt kit; mutations include D770\_N771insSVD, D770\_N771insNPG…
What they're measuring
1
Objective response rate a in patients with estimated glomerular filtration rate (EGFR) exon 20 mutant non-small Cell Lung Cancer (NSCLC) (Cohort 1)
Timeframe: Up to 4 years
2
Objective response rate a in patients with human epidermal growth factor receptor 2 (HER2) exon 20 mutant non-small Cell Lung Cancer (NSCLC) (Cohort 2)