Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill targets Hard-to-Treat lung cancer mutations

NCT ID NCT07699328

Disease control Sponsor: Voronoi, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests an experimental oral drug called VRN110755 in people with a specific type of lung cancer (EGFR-mutant non-small cell lung cancer). The drug is designed to block cancer growth by targeting the EGFR protein and certain resistance mutations, including C797S. The trial aims to find the safest dose and see if the drug can shrink tumors, especially in patients whose cancer has stopped responding to other EGFR-targeted therapies.

What this could mean

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

Active substance
VRN110755 (an oral drug that targets specific EGFR mutations in lung cancer cells)
What this could lead to
If successful, VRN110755 could offer a new treatment option for people with EGFR-mutant lung cancer, especially those whose cancer has stopped responding to other targeted therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or may cause unexpected side effects. It is not yet known if it will work better than existing treatments.

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 315 people

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

Started

Mar 2024

Expected to finish

Jan 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.

Inclusion Criteria: * Adults aged 18 years or older (19 years or older in the Republic of Korea). * Able to understand, sign, and provide written informed consent. * Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation. * At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. * Documented EGFR mutation determined by tumor tissue or liquid biopsy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Able to swallow oral capsules and comply with study procedures. * Women of childbearing potential must have a negative pregnancy test, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 months after the last safety follow-up visit. Men must agree to use effective contraception during the study and for 6 months after the last safety follow-up visit. * No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator. * Participants must meet the disease-specific eligibility criteria for one of the following study groups: * Phase 1a * NSCLC with EGFR activating, resistant, uncommon, or complex mutations, including but not limited to exon 19 deletion (Del19), L858R, C797S, or other uncommon EGFR mutations. * Radiographic disease progression following at least 2 cycles of prior EGFR tyrosine kinase inhibitor (TKI) therapy or discontinuation of prior EGFR TKI therapy because of toxicity, with no remaining standard therapy expected to provide clinical benefit. * Phase 1b - Cohort A * NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation following disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib). * Phase 1b - Cohort B * Treatment-naïve NSCLC with common EGFR mutations. * Phase 1b - Cohort C * NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations) previously treated with at least one systemic therapy, including an EGFR TKI, with no remaining standard therapy expected to provide clinical benefit. * Phase 1b - Cohort D * Treatment-naïve NSCLC with atypical EGFR mutations. Exclusion Criteria: * Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. * Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia. * Pregnant or breastfeeding, or planning to become pregnant during the study. * NSCLC with an EGFR or HER2 exon 20 insertion mutation. * Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured. * Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria. * Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment. * Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection. * Receipt of a live vaccine within 4 weeks before the first dose of study treatment. * Use of strong or moderate cytochrome P450 (CYP) 3A inhibitors or inducers, certain herbal supplements, or other prohibited medications within the protocol-defined washout period. * Major surgery within 4 weeks before the first dose of study treatment or incomplete recovery from major surgery. * Receipt of prior anticancer therapy within the protocol-defined washout period, including systemic therapy, immunotherapy, or radiotherapy. * Symptomatic or uncontrolled central nervous system (CNS) metastases or spinal cord compression requiring increasing doses of corticosteroids. Participants with treated and stable CNS metastases or asymptomatic CNS disease may be eligible. * Requirement for systemic corticosteroid therapy exceeding the protocol-defined limit. * Clinically significant cardiovascular disease, including prolonged QT interval, clinically significant arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, uncontrolled hypertension, reduced left ventricular ejection fraction, or use of medications known to prolong the QT interval. * History of interstitial lung disease, noninfectious pneumonitis requiring steroid treatment, or current interstitial lung disease or pneumonitis. * Inability to swallow oral capsules or gastrointestinal disorders that may interfere with absorption of study treatment. * Known allergy or hypersensitivity to VRN110755 or any of its components. * Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results. * Use of proton pump inhibitors, histamine-2 receptor antagonists, or locally acting antacids within the protocol-defined washout period or inability to comply with protocol requirements for acid-reducing medications. * For Phase 1b and Phase 2 only: Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification; ALK, ROS1, NTRK, or RET fusion; or BRAF V600E or KRAS G12X mutation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for EGFR-mutant non-small cell lung cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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-mutant non-small cell lung cancer

How to take part

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

  1. The places running it

    29 sites in 10 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

  • AP-HM Hôpital Nord

    RECRUITING

    Marseille, Bouches-du-Rhône, 13915, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, Côte-d'Or, 21079, France

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 50586, Malaysia

  • Hospital Regional Universitario de Málaga - Hospital Civil

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Umum Sarawak

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Institut Kanser Negara

    RECRUITING

    Putrajaya, 62250, Malaysia

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Monash Medical Centre Clayton

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Phramongkutklao Hospital

    RECRUITING

    Thung Phaya Thai, Bangkok Metropolis, 10400, Thailand

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Songklanagarind Hospital Prince of Songkla University

    RECRUITING

    Hat Yai, Changwat Songkhla, 90100, Thailand

  • Southern Oncology Clinical Research Unit

    RECRUITING

    Bedford Park, South Australia, 05042, Australia

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 11031, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • Tan Tock Seng Hospital

    RECRUITING

    Singapore, 308433, Singapore

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 16247, South Korea

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

More trials for these conditions

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