About the study

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
2. Patient has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
3. Prior treatment status:
4. Cohorts 1 and 2: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
5. Cohorts 3 and 4: Patient is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry.
6. Cohort 5: Patients who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed
7. Cohort 6: Patients with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
8. Cohort 7: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
9. Specific mutations:
10. Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
11. Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
12. Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
13. Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression)
14. Cohort 7: Documented EGFR or HER2 activating mutations
15. Patient has adequate organ function at Baseline Key

Exclusion criteria

1. Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible (Cohorts 1 and 2).
2. Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed
3. Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully-treated and stable, early-stage prostate cancer, or carcinoma in situ of the cervix or breast without need of treatment
4. Patient is pregnant or breast-feeding

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.