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

9. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

315

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Estimate of Maximum Tolerated Dose (MTD) of VRN110755
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From baseline through End of Treatment (up to approximately 6 years)
From baseline through End of Treatment (up to approximately 6 years)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Plasma PK of VRN110755 - Maximum Plasma Concentration (Cmax)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Voronoi, Inc

Ermittler

  • Studienleiter: Hongryul Jung, PhD, Voronoi, Inc

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. März 2024

Primärer Abschluss (Geschätzt)

1. Januar 2029

Studienabschluss (Geschätzt)

1. Januar 2029

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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