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EGFR-Mutant Non-Small Cell Lung CancerPhase 1/2REACH-EGFRNCT07699328

A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

A Phase 1/2 study testing VRN110755 in people with EGFR-Mutant Non-Small Cell Lung Cancer, run by Voronoi, Inc at 29 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This first-in-human, Phase 1/2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
EGFR-Mutant Non-Small Cell Lung Cancer
What is being tested?
VRN110755
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
29 sitesin 10 countries
Study dates
26 Mar 2024to 1 Oct 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 21Show fewer
  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

29 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Trial Information contact

+82 32 219 7849

information_clinicaltrial_11@voronoi.io

29 sites in 10 countries

South Korea5 sites, 5 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

    Ki Hyeong Lee

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Yu Jung Kim

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Min Hee Hong

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Se-Hoon Lee

    Recruiting

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

    Suwon, Gyeonggi-do, 16247

    Byoung Yong Shim

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Jen-Yu Hung

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Tsung-Ying Yang

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Chia-Chi Lin

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 11031

    Chao-Hua Chiu

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Yung-Hung Luo

    Recruiting

Other trials in Taiwan

Malaysia4 sites, 4 recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

    Muthukkumaran Thiagarajan

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Jiunn Liang Tan

    Recruiting

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586

    Pei Jye Voon

    Recruiting

  • Institut Kanser Negara

    Putrajaya, 62250

    Yoke Fui Wong

    Recruiting

Other trials in Malaysia

Spain4 sites, 4 recruiting

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Enric Carcereny Costa

    Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

    Noelia Vilariño Quintela

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Santiago Ponce Aix

    Recruiting

  • Hospital Regional Universitario de Málaga - Hospital Civil

    Málaga, 29011

    Manuel Cobo Dols

    Recruiting

Other trials in Spain

Australia2 sites, 2 recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, 05042

    Shawgi Sukumaran

    Recruiting

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

    Surein Arulananda

    Recruiting

Other trials in Australia

France2 sites, 2 recruiting

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

    François Ghiringhelli

    Recruiting

  • AP-HM Hôpital Nord

    Marseille, Bouches-du-Rhône, 13915

    Pascale Tomasini

    Recruiting

Other trials in France

Hong Kong2 sites, 2 recruiting

  • Prince of Wales Hospital

    Hong Kong, 999077

    Molly Li

    Recruiting

  • Queen Mary Hospital

    Hong Kong, 999077

    Victor Lee

    Recruiting

Other trials in Hong Kong

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore

    Singapore, 168583

    Aaron Tan

    Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433

    Puey Ling Chia

    Recruiting

Other trials in Singapore

Thailand2 sites, 2 recruiting

  • Songklanagarind Hospital Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90100

    Sarayut Geater

    Recruiting

  • Phramongkutklao Hospital

    Thung Phaya Thai, Bangkok Metropolis, 10400

    Naiyarat Prasongsook

    Recruiting

Other trials in Thailand

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Natasha Leighl

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

This first-in-human, Phase 1/2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).

The study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.

Read the detailed description

This is a Phase 1/2, multicenter, open-label, non-randomized, dose-escalation and dose-expansion clinical trial evaluating VRN110755 administered as oral monotherapy once daily in 28-day treatment cycles.

Phase 1a uses a standard 3+3 dose-escalation design to evaluate safety, tolerability, dose-limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity and to determine the maximum tolerated dose (MTD).

Phase 1b evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity across molecularly defined EGFR-mutant NSCLC cohorts and determines the recommended Phase 2 dose (RP2D).

Following determination of the RP2D, selected expansion cohorts will continue into the Phase 2 portion to further evaluate the efficacy, safety, tolerability, and pharmacokinetics of VRN110755. The specific Phase 2 cohorts will be selected based on the safety and efficacy data generated during Phase 1b.

Participants remain on treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of another anticancer therapy, death, or study completion.

Being tested
VRN110755
Keywords
NSCLC, EGFR, Epidermal Growth Factor Receptor, Non-Small Cell Lung Cancer, EGFR Mutation, C797S, EGFR Tyrosine Kinase Inhibitor Resistance
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRN110755Drug

    VRN110755 is an investigational highly selective oral EGFR inhibitor supplied as capsules for oral administration. The drug is designed to target activating EGFR mutations and selected resistance mutations, including C797S, in patients with EGFR-mutant NSCLC.

Study groups in NCT07699328
Study groupRoleWhat they receive
Phase 1a Dose EscalationExperimentalParticipants with advanced, metastatic, or recurrent EGFR-mutant non-small cell lung cancer (NSCLC) who have experienced disease progression following prior EGFR tyrosine kinase inhibitor (TKI) therapy and harbor activating, resistant, uncommon, or complex EGFR mutations. Participants receive escalating dose levels of VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity and to determine the maximum tolerated dose (MTD).
Receives: Drug: VRN110755
Phase 1b Cohort AExperimentalParticipants with EGFR-mutant NSCLC harboring exon 19 deletion or exon 21 L858R mutations and a C797X resistance mutation following progression on first-line third-generation EGFR TKI therapy, including osimertinib, lazertinib, or aumolertinib. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity and to support selection of the recommended Phase 2 dose.
Receives: Drug: VRN110755
Phase 1b Cohort BExperimentalTreatment-naïve participants with NSCLC harboring common EGFR mutations. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients who have not previously received systemic treatment for EGFR-mutant NSCLC.
Receives: Drug: VRN110755
Phase 1b Cohort CExperimentalParticipants with NSCLC harboring atypical or uncommon EGFR mutations, including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations thereof, who have previously received at least one prior systemic therapy, including an EGFR TKI, and have no remaining standard treatment options expected to provide clinical benefit. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity.
Receives: Drug: VRN110755
Phase 1b Cohort DExperimentalTreatment-naïve participants with NSCLC harboring atypical EGFR mutations. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients who have not previously received systemic treatment for EGFR-mutant NSCLC.
Receives: Drug: VRN110755

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate of Maximum Tolerated Dose (MTD) of VRN110755

    This will be based on dose-limiting toxicities (DLTs) observed during the DLT evaluation period.

    Measured: 28 days

  2. Number of participants with dose-limiting toxicities (DLTs) following treatment with VRN110755

    Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria during the DLT evaluation period.

    Measured: 28 days

  3. Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation

    Measured: From first dose until end of study (up to approximately 6 years)

  4. Number of participants with changes in vital signs from baseline following treatment with VRN110755

    Vital signs include blood pressure, pulse rate, respiratory rate, body temperature, and oxygen saturation.

    Measured: From baseline through End of Treatment (up to approximately 6 years)

  5. Number of participants with changes in laboratory test results from baseline following treatment with VRN110755

    Laboratory evaluations include hematology, clinical chemistry, coagulation, and urinalysis assessments.

    Measured: From baseline through End of Treatment (up to approximately 6 years)

  6. Number of participants with changes in physical examination findings from baseline following treatment with VRN110755

    Physical examinations include complete physical examinations at screening and End of Treatment and symptom-directed physical examinations during study treatment.

    Measured: From baseline through End of Treatment (up to approximately 6 years)

  7. Number of participants with changes in ophthalmologic examination findings from baseline following treatment with VRN110755

    Ophthalmologic examinations include best corrected visual acuity, intraocular pressure, slit-lamp examination, spectral-domain optical coherence tomography (SD-OCT), confrontation visual fields, and fundoscopic examination.

    Measured: From baseline through End of Treatment (up to approximately 6 years)

  8. Number of participants with changes in electrocardiogram (ECG) parameters from baseline following treatment with VRN110755

    Electrocardiogram assessments include 12-lead ECG parameters, including QT interval corrected using Fridericia's formula (QTcF).

    Measured: From baseline through End of Treatment (up to approximately 6 years)

  9. Number of participants with changes in Eastern Cooperative Oncology Group (ECOG) Performance Status from baseline following treatment with VRN110755

    Measured: From baseline through End of Treatment (up to approximately 6 years)

Secondary outcomes (20)

  1. Plasma PK of VRN110755 - Maximum Plasma Concentration (Cmax)

    Maximum observed plasma concentration of VRN110755.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  2. Plasma PK of VRN110755 - Minimum Plasma Concentration (Cmin)

    Minimum observed plasma concentration of VRN110755.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  3. Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast)

    Area under the plasma concentration-time curve from time zero to the last measurable concentration of VRN110755.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  4. Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCτ)

    Area under the plasma concentration-time curve over the dosing interval at steady state for VRN110755.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  5. Plasma PK of VRN110755 - Time to Maximum Plasma Concentration (Tmax)

    Time from dosing to the maximum observed plasma concentration of VRN110755.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  6. Plasma PK of VRN110755 - Terminal Elimination Rate Constant (λz)

    Terminal elimination rate constant of VRN110755 estimated from the terminal log-linear portion of the plasma concentration-time curve.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  7. Plasma PK of VRN110755 - Apparent Terminal Elimination Half-life (t½)

    Apparent terminal elimination half-life of VRN110755 estimated from the terminal elimination phase of the plasma concentration-time curve.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  8. Plasma PK of VRN110755 - Apparent Volume of Distribution During the Terminal Phase (Vz/F)

    Apparent volume of distribution during the terminal elimination phase of VRN110755 following oral administration.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  9. Plasma PK of VRN110755 - Apparent Total Plasma Clearance (CL/F)

    Apparent total plasma clearance of VRN110755 following oral administration.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  10. Plasma PK of VRN110755 - Trough Plasma Concentration (Ctrough)

    Plasma concentration of VRN110755 immediately before the next scheduled dose at steady state.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  11. Plasma PK of VRN110755 - Mean Residence Time Based on AUClast (MRTlast)

    Mean residence time of VRN110755 in the body calculated based on AUClast.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  12. Plasma PK of VRN110755 - Accumulation Ratio (Rac)

    Accumulation ratio of VRN110755 following repeated once-daily dosing, calculated using protocol-specified pharmacokinetic parameters.

    Measured: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

  13. Change from Baseline in Circulating Tumor DNA (ctDNA)

    Change from baseline in circulating tumor DNA (ctDNA) levels, including EGFR Del19, L858R, Del19/C797S, L858R/C797S, C797S, and other protocol-specified EGFR mutations.

    Measured: Screening, Day 1 of protocol-specified treatment cycles (each cycle is 28 days) and End of Treatment (up to approximately 6 years)

  14. Objective Response Rate (ORR)

    The proportion of participants whose best overall response is a confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

    Measured: From first dose until end of study (up to approximately 6 years)

  15. Duration of Response (DOR)

    Duration of response (DOR), defined as the time from the first documented confirmed complete response or confirmed partial response until disease progression or death from any cause.

    Measured: From first dose until end of study (up to approximately 6 years)

  16. Number of participants with Disease Control Rate (DCR)

    Disease control rate (DCR), defined as the proportion of participants achieving confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to RECIST Version 1.1.

    Measured: From first dose until end of study (up to approximately 6 years)

  17. Progression-Free Survival (PFS)

    Progression-free survival (PFS), defined as the time from the first dose of study treatment until documented disease progression or death from any cause.

    Measured: From first dose until end of study (up to approximately 6 years)

  18. Overall Survival (OS)

    Overall survival (OS), defined as the time from the first dose of study treatment until death from any cause.

    Measured: From first dose until end of study (up to approximately 6 years)

  19. Intracranial Objective Response Rate (Intracranial ORR)

    The proportion of participants with brain metastases who achieve a confirmed intracranial complete response or partial response according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

    Measured: From first dose until end of study (up to approximately 6 years)

  20. Intracranial Progression-Free Survival (Intracranial PFS)

    Intracranial progression-free survival assessed according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria in participants with brain metastases.

    Measured: From first dose until end of study (up to approximately 6 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start26 Mar 2024
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Participants will enroll sequentially into Phase 1a dose-escalation cohorts followed by Phase 1b dose-expansion cohorts and Phase 2 cohorts.
Masking
None (open label)
Enrolment
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699328
Sponsor's protocol ID
VRN110755_01
Other IDs
2025-523122-40-00, 2025
Acronym
REACH-EGFR
Status last verified
Nov 2026
First submitted
1 Jul 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VRN110755 in people with EGFR-Mutant Non-Small Cell Lung Cancer, run by Voronoi, Inc at 29 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in South Korea, Taiwan, Malaysia, Spain, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Information (+82 32 219 7849, information_clinicaltrial_11@voronoi.io), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate of Maximum Tolerated Dose (MTD) of VRN110755 (time frame: 28 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07699328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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