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

What is the Purpose of this Study?

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.
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?

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.

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