For Healthcare Professionals

Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation


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:


  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


  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
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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 949-788-6700Email iconEmail Study Center

Study’s details



Age (in years)

18 - 200


Phase 2

Participants needed


Est. Completion Date

Dec 2023

Treatment type



Spectrum Pharmaceuticals, Inc identifier


Study number


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