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TerminatedPhase 2NCT03318939
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPoziotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 12, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?63 U.S. locations

Locations may change over time.

Who runs it?Spectrum Pharmaceuticals, Inc

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Spectrum Pharmaceuticals, Inc
Interventions being studied
Drug: Poziotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
EGFR→HER2→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • Participant must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
  • Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
  • Prior treatment status:
  • Cohorts 1 and 2: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
  • Cohorts 3 and 4: Participant 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.
  • Cohort 5: Participants who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed
  • Cohort 6: Participant with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
  • Cohort 7: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
  • Specific mutations:
  • Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
  • Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
  • Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
  • Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression)
  • Cohort 7: Documented EGFR or HER2 activating mutations
  • Participant has adequate organ function at Baseline Key
Reasons someone may not be able to joinExclusion criteria
  • Participant 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).
  • Participant 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
  • Participant 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
  • Participant is pregnant or breast-feeding

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic HospitalPhoenix, Arizona
  • Oncology Physician's Network Inc./OPN HealthcareArcadia, California
  • City of HopeDuarte, California
  • UCSD -Moores Cancer CenterLa Jolla, California
  • Pacific Shores Medical GroupLong Beach, California
  • Los Angeles Hematology Oncology Medical GroupLos Angeles, California
  • USC/Norris Comprehensive Cancer CenterLos Angeles, California
  • UC Davis Comprehensive Cancer CenterSacramento, California
  • UCSF Helen Diller Comprehensive Cancer Center at Mt ZionSan Francisco, California
  • UCLA Hematology/OncologySanta Monica, California
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, California
  • Kaiser Permanente Medical CenterVallejo, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 12, 2026. Always confirm current availability with the study team.

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