Spectrum SPI-POZ-202 (Non-Small Cell Lung Cancer)

What is the Purpose of this Study?

Based upon your Exon 20 insertion mutation-positive status (EGFR or HER2), you will be assigned to one of 4 groups and you will:
- Take poziotinib pills (10 or 16 mg) by mouth daily with breakfast at the same time each morning.
- Have blood samples and possibly a small piece of tissue removed from your lung to see what type of lung cancer cells you have
- Have other tests, exams, and procedures for study purposes and your standard of care.
- Be in the study for up to 24 months after the start of study drug or until your condition worsens or you have intolerable side effects.
What is the Condition Being Studied?
Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 Exon 20 Insertion Mutation

Who Can Participate in this Study?

Adults who have confirmed non-small cell lung cancer with EGFR or HER2 Exon 20 Insertion Mutation.

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to find out if a study drug poziotinib is safe and effective in treating NSCLC with EGFR or HER2 Exon 20 Insertion Mutation.

Study Details

Full Title
A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)
Principal Investigator

Contacts
Protocol Number
IRB:
PRO00087877

NCT:
NCT03318939
ClinicalTrials.gov
View on ClinicalTrials.gov