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

9 luglio 2026 aggiornato da: Voronoi, Inc

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

315

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Somi Lee
  • Numero di telefono: 00 82 32 219 7849
  • Email: somi@voronoi.io

Luoghi di studio

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 05042
        • Reclutamento
        • Southern Oncology Clinical Research Unit
        • Investigatore principale:
          • Shawgi Sukumaran
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Reclutamento
        • Monash Medical Centre Clayton
        • Investigatore principale:
          • Surein Arulananda
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Reclutamento
        • Princess Margaret Cancer Centre
        • Investigatore principale:
          • Natasha Leighl
  • Corea del Sud
      • Seoul, Corea del Sud, 06351
        • Reclutamento
        • Samsung Medical Center
        • Investigatore principale:
          • Se-Hoon Lee
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Severance Hospital Yonsei University Health System
        • Investigatore principale:
          • Min Hee Hong
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
        • Reclutamento
        • Seoul National University Bundang Hospital
        • Investigatore principale:
          • Yu Jung Kim
      • Suwon, Gyeonggi-do, Corea del Sud, 16247
        • Reclutamento
        • The Catholic University of Korea, St. Vincent's Hospital
        • Investigatore principale:
          • Byoung Yong Shim
    • North Chungcheong
      • Cheongju-si, North Chungcheong, Corea del Sud, 28644
        • Reclutamento
        • Chungbuk National University Hospital
        • Investigatore principale:
          • Ki Hyeong Lee
  • Francia
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, Francia, 13915
        • Reclutamento
        • AP-HM Hôpital Nord
        • Investigatore principale:
          • Pascale Tomasini
    • Côte-d'Or
      • Dijon, Côte-d'Or, Francia, 21079
        • Reclutamento
        • Centre Georges François Leclerc
        • Investigatore principale:
          • François Ghiringhelli
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Reclutamento
        • Queen Mary Hospital
        • Investigatore principale:
          • Victor Lee
      • Hong Kong, Hong Kong, 999077
        • Reclutamento
        • Prince of Wales Hospital
        • Investigatore principale:
          • Molly Li
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Reclutamento
        • University Malaya Medical Centre
        • Investigatore principale:
          • Jiunn Liang Tan
      • Kuala Lumpur, Malaysia, 50586
        • Reclutamento
        • Hospital Kuala Lumpur
        • Investigatore principale:
          • Muthukkumaran Thiagarajan
      • Putrajaya, Malaysia, 62250
        • Reclutamento
        • Institut Kanser Negara
        • Investigatore principale:
          • Yoke Fui Wong
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Reclutamento
        • Hospital Umum Sarawak
        • Investigatore principale:
          • Pei Jye Voon
  • Singapore
      • Singapore, Singapore, 308433
        • Reclutamento
        • Tan Tock Seng Hospital
        • Investigatore principale:
          • Puey Ling Chia
      • Singapore, Singapore, 168583
        • Reclutamento
        • National Cancer Centre Singapore
        • Investigatore principale:
          • Aaron Tan
  • Spagna
      • Madrid, Spagna, 28041
        • Reclutamento
        • Hospital Universitario 12 de Octubre
        • Investigatore principale:
          • Santiago Ponce Aix
      • Málaga, Spagna, 29011
        • Reclutamento
        • Hospital Regional Universitario de Málaga - Hospital Civil
        • Investigatore principale:
          • Manuel Cobo Dols
    • Barcelona
      • Badalona, Barcelona, Spagna, 08916
        • Reclutamento
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol
        • Investigatore principale:
          • Enric Carcereny Costa
      • L'Hospitalet de Llobregat, Barcelona, Spagna, 08908
        • Reclutamento
        • ICO l'Hospitalet - Hospital Duran i Reynals
        • Investigatore principale:
          • Noelia Vilariño Quintela
  • Tailandia
    • Bangkok Metropolis
      • Thung Phaya Thai, Bangkok Metropolis, Tailandia, 10400
        • Reclutamento
        • Phramongkutklao Hospital
        • Investigatore principale:
          • Naiyarat Prasongsook
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Tailandia, 90100
        • Reclutamento
        • Songklanagarind Hospital Prince of Songkla University
        • Investigatore principale:
          • Sarayut Geater
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Reclutamento
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Investigatore principale:
          • Jen-Yu Hung
      • Taichung, Taiwan, 407219
        • Reclutamento
        • Taichung Veterans General Hospital
        • Investigatore principale:
          • Tsung-Ying Yang
      • Taipei, Taiwan, 10002
        • Reclutamento
        • National Taiwan University Hospital
        • Investigatore principale:
          • Chia-Chi Lin
      • Taipei, Taiwan, 11031
        • Reclutamento
        • Taipei Medical University Hospital
        • Investigatore principale:
          • Chao-Hua Chiu
      • Taipei, Taiwan, 112201
        • Reclutamento
        • Taipei Veterans General Hospital
        • Investigatore principale:
          • Yung-Hung Luo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Phase 1a Dose Escalation
Participants 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).
Droga: VRN110755
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.
Sperimentale: Phase 1b Cohort A
Participants 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.
Droga: VRN110755
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.
Sperimentale: Phase 1b Cohort B
Treatment-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.
Droga: VRN110755
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.
Sperimentale: Phase 1b Cohort C
Participants 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.
Droga: VRN110755
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.
Sperimentale: Phase 1b Cohort D
Treatment-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.
Droga: VRN110755
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Estimate of Maximum Tolerated Dose (MTD) of VRN110755
Lasso di tempo: 28 days
This will be based on dose-limiting toxicities (DLTs) observed during the DLT evaluation period.
28 days
Number of participants with dose-limiting toxicities (DLTs) following treatment with VRN110755
Lasso di tempo: 28 days
Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria during the DLT evaluation period.
28 days
Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
From first dose until end of study (up to approximately 6 years)
Number of participants with changes in vital signs from baseline following treatment with VRN110755
Lasso di tempo: From baseline through End of Treatment (up to approximately 6 years)
Vital signs include blood pressure, pulse rate, respiratory rate, body temperature, and oxygen saturation.
From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in laboratory test results from baseline following treatment with VRN110755
Lasso di tempo: From baseline through End of Treatment (up to approximately 6 years)
Laboratory evaluations include hematology, clinical chemistry, coagulation, and urinalysis assessments.
From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in physical examination findings from baseline following treatment with VRN110755
Lasso di tempo: From baseline through End of Treatment (up to approximately 6 years)
Physical examinations include complete physical examinations at screening and End of Treatment and symptom-directed physical examinations during study treatment.
From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in ophthalmologic examination findings from baseline following treatment with VRN110755
Lasso di tempo: From baseline through End of Treatment (up to approximately 6 years)
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.
From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in electrocardiogram (ECG) parameters from baseline following treatment with VRN110755
Lasso di tempo: From baseline through End of Treatment (up to approximately 6 years)
Electrocardiogram assessments include 12-lead ECG parameters, including QT interval corrected using Fridericia's formula (QTcF).
From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in Eastern Cooperative Oncology Group (ECOG) Performance Status from baseline following treatment with VRN110755
Lasso di tempo: From baseline through End of Treatment (up to approximately 6 years)
From baseline through End of Treatment (up to approximately 6 years)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plasma PK of VRN110755 - Maximum Plasma Concentration (Cmax)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Maximum observed plasma concentration of VRN110755.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Minimum Plasma Concentration (Cmin)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Minimum observed plasma concentration of VRN110755.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Area under the plasma concentration-time curve from time zero to the last measurable concentration of VRN110755.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCτ)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Area under the plasma concentration-time curve over the dosing interval at steady state for VRN110755.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Time to Maximum Plasma Concentration (Tmax)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Time from dosing to the maximum observed plasma concentration of VRN110755.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Terminal Elimination Rate Constant (λz)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Terminal elimination rate constant of VRN110755 estimated from the terminal log-linear portion of the plasma concentration-time curve.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Apparent Terminal Elimination Half-life (t½)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Apparent terminal elimination half-life of VRN110755 estimated from the terminal elimination phase of the plasma concentration-time curve.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Apparent volume of distribution during the terminal elimination phase of VRN110755 following oral administration.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Apparent Total Plasma Clearance (CL/F)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Apparent total plasma clearance of VRN110755 following oral administration.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Trough Plasma Concentration (Ctrough)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma concentration of VRN110755 immediately before the next scheduled dose at steady state.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Mean Residence Time Based on AUClast (MRTlast)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Mean residence time of VRN110755 in the body calculated based on AUClast.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Plasma PK of VRN110755 - Accumulation Ratio (Rac)
Lasso di tempo: Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Accumulation ratio of VRN110755 following repeated once-daily dosing, calculated using protocol-specified pharmacokinetic parameters.
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
Change from Baseline in Circulating Tumor DNA (ctDNA)
Lasso di tempo: Screening, Day 1 of protocol-specified treatment cycles (each cycle is 28 days) and End of Treatment (up to approximately 6 years)
Change from baseline in circulating tumor DNA (ctDNA) levels, including EGFR Del19, L858R, Del19/C797S, L858R/C797S, C797S, and other protocol-specified EGFR mutations.
Screening, Day 1 of protocol-specified treatment cycles (each cycle is 28 days) and End of Treatment (up to approximately 6 years)
Objective Response Rate (ORR)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
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.
From first dose until end of study (up to approximately 6 years)
Duration of Response (DOR)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
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.
From first dose until end of study (up to approximately 6 years)
Number of participants with Disease Control Rate (DCR)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
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.
From first dose until end of study (up to approximately 6 years)
Progression-Free Survival (PFS)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
Progression-free survival (PFS), defined as the time from the first dose of study treatment until documented disease progression or death from any cause.
From first dose until end of study (up to approximately 6 years)
Overall Survival (OS)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
Overall survival (OS), defined as the time from the first dose of study treatment until death from any cause.
From first dose until end of study (up to approximately 6 years)
Intracranial Objective Response Rate (Intracranial ORR)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
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.
From first dose until end of study (up to approximately 6 years)
Intracranial Progression-Free Survival (Intracranial PFS)
Lasso di tempo: From first dose until end of study (up to approximately 6 years)
Intracranial progression-free survival assessed according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria in participants with brain metastases.
From first dose until end of study (up to approximately 6 years)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Voronoi, Inc

Investigatori

  • Direttore dello studio: Hongryul Jung, PhD, Voronoi, Inc

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 marzo 2024

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

1 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VRN110755_01
  • 2025-523122-40-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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3
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