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Targeted drug shows promise for Hard-to-Treat lung cancer

NCT ID NCT03318939

Disease control Sponsor: Spectrum Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called poziotinib in 648 people with advanced non-small cell lung cancer that has specific genetic changes (EGFR or HER2 exon 20 mutations). The goal was to see if the drug could shrink tumors. The study was stopped early, but results showed some patients had their tumors shrink. Common side effects included skin rashes and diarrhea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

648 people

The number who actually took part.

Started

Oct 2017

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 Exclusion 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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC

Contacts and locations

Locations

  • Ambroise Pare University Hospital Center

    Mons, Belgium

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • CTCA - Eastern Regional Medical Center

    Philadelphia, Pennsylvania, 19124, United States

  • CTCA - Midwestern Regional Medical Center

    Zion, Illinois, 60099, United States

  • CTCA - Southeastern Regional Medical Center

    Newnan, Georgia, 30265, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Florida Hospital

    Orlando, Florida, 32804, United States

  • General Hospital Delta

    Roeselare, Belgium

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Gustave Roussy Oncology Institute, Department of Medical Oncology

    Villejuif, France

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Hadassah Medical Center

    Jerusalem, Israel

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401, United States

  • Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires

    Toulouse, France

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • London Regional Cancer Program

    London, Ontario, N6A 5W9, Canada

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404, United States

  • Montefiore Einstein Medical Center for Cancer Care

    The Bronx, New York, 10461, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1

    Rome, Italy

  • National Cancer Institute, IRCCS, Department of Medical Oncology

    Milan, Italy

  • North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists

    The Bronx, New York, 10469, United States

  • North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists

    Port Jefferson Station, New York, 11776, United States

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146, United States

  • Oncology Physician's Network Inc./OPN Healthcare

    Arcadia, California, 91007, United States

  • Pacific Shores Medical Group

    Long Beach, California, 90813, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center

    Petah Tikva, Israel

  • Rambam Healthcare Campus

    Haifa, Israel

  • Rocky Mountain Cancer Center

    Boulder, Colorado, 80303, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Saint Luc University Hospital

    Brussels, Belgium

  • Santa Maria delle Croci Hospital

    Ravenna, Italy

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Soroka Medical Center

    Beersheba, Israel

  • Texas Oncology- Austin

    Austin, Texas, 78745, United States

  • The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.

    Winter Haven, Florida, 33881, United States

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • UCLA Hematology/Oncology

    Santa Monica, California, 90404, United States

  • UCSD -Moores Cancer Center

    La Jolla, California, 92093, United States

  • UCSF Helen Diller Comprehensive Cancer Center at Mt Zion

    San Francisco, California, 94115, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607, United States

  • University Hospital 12 de Octubre

    Madrid, Spain

  • University Hospital Germans Trias i Pujol, Department of Medical Oncology

    Barcelona, Spain

  • University Hospitals Leuven

    Leuven, Belgium

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.