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

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 the Study?

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

Age Group

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
Medical Oncologist
Protocol Number
IRB: PRO00087877
NCT: NCT03318939
Phase II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center