Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for rare lung cancer? poziotinib trial targets HER2 mutations

NCT ID NCT05378763

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 3 times

Summary

This phase 3 study compares the experimental drug poziotinib to the standard chemotherapy docetaxel in 268 people with advanced non-small cell lung cancer that has a specific HER2 mutation. Participants must have already tried at least one prior treatment. The main goal is to see if poziotinib can delay cancer growth longer than docetaxel. The trial is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
poziotinib
What this could lead to
If successful, poziotinib could offer a new targeted treatment option for people with a specific type of lung cancer that has few approved therapies.
What could go wrong
The trial is currently suspended, and it's a head-to-head comparison against an existing chemotherapy. Success is not guaranteed, and side effects from poziotinib may be significant.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 268 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

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.

Inclusion Criteria: Participant must: 1. Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements 2. Have histologically or cytologically confirmed NSCLC 3. Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment 4. Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC, including platinum and a checkpoint inhibitor (CPI) therapy, unless the investigator affirms that a CPI was not medically indicated. 5. Have documentation of HER2 exon 20 mutation 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7. Have adequate hematologic, hepatic, and renal function at Baseline as per protocol Exclusion Criteria: Participant: 1. Has had previous treatment with poziotinib for treatment of NSCLC 2. Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations 3. Has had previous treatment with docetaxel for locally advanced or metastatic NSCLC. If docetaxel was received in the neo-adjuvant or adjuvant setting, progressive disease must have occurred ≥6 months after the last dose to be eligible 4. Has spinal cord compression or leptomeningeal disease 5. Has a high risk of cardiac disease, as determined by the Investigator 6. Has a history of, or signs of Grade ≥2 pneumonitis on current imaging studies 7. Is unable to take drugs orally 8. Is pregnant or breast-feeding

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for NSCLC are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bond Clinic, P.A.

    Winter Haven, Florida, 33880, United States

More trials for these conditions

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