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New pill takes aim at tough lung cancer mutations

NCT ID NCT06043817

Disease control Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests an experimental oral drug called STX-721 in people with advanced non-small cell lung cancer that has specific EGFR or HER2 gene mutations. The trial has three parts: first finding a safe dose, then confirming the best dose, and finally expanding to more participants to see how well the drug shrinks tumors. About 345 people will take part across multiple sites.

What this could mean

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

Active substance
STX-721 (also called PFL-721), an oral drug
What this could lead to
If it works, this could offer a new targeted treatment option for people with a hard-to-treat form of lung cancer that has specific genetic mutations.
What could go wrong
This is an early first-in-human study, so safety and effectiveness are not yet known. The drug may not shrink tumors or could cause side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 345 people

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

Started

Sep 2023

Expected to finish

Dec 2029

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.

Key Inclusion Criteria: 1. Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation 2. Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR/HER2 exon 20 insertion mutations confirmed by qualified local laboratories 3. Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not more than 2, prior lines of approved treatment for advanced or metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated 4. Has documented tumor progression (based on radiological imaging) 5. Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling 6. Has at least one measurable tumor lesion per RECIST v1.1 7. Is ≥18 years of age at the time of signing the ICF 8. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Key Exclusion Criteria: 1. Has a tumor that is known to harbor EGFR ex20ins p.H773\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations 2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC 3. Has symptomatic brain or spinal metastases 4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy 5. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments

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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.

EGFR/HER2 exon 20 insertion mutation Non-small cell lung cancer NSCLC

How to take part

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

  1. The places running it

    25 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • CHA Bundang Medical Center, CHA University

    RECRUITING

    Seongnam-si, 13496, South Korea

  • Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30

    RECRUITING

    Berlin, 12203, Germany

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, 28644, South Korea

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope

    RECRUITING

    Huntington Beach, California, 92648, United States

  • City of Hope

    RECRUITING

    Irvine, California, 92618, United States

  • EDOG Institut de Cancerologie de l'Ouest - PPDS

    RECRUITING

    Saint-Herblain, Loire-Atlantique, 44115, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Hospital Regional Universitario de Malaga - Hospital General

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Institut Claudius Regaud - PPDS

    RECRUITING

    Toulouse, 31059, France

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    RECRUITING

    Barcelona, 8035, Spain

  • Levine Cancer Institute - Charlotte

    RECRUITING

    Charlotte, North Carolina, 28204-2990, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031-2171, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

    RECRUITING

    Amsterdam, 1066, Netherlands

  • SCRI Oncology Partners - PPDS

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START - Rioja Hospital Universitario San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • Thomas Jefferson University Research Facility

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • University of Utah - Huntsman Cancer Institute - PPDS

    RECRUITING

    Salt Lake City, Utah, 84112-5550, United States

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    RECRUITING

    Dresden, 01307, Germany

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