OncoMatch/Clinical Trials/NCT07699328
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
Is NCT07699328 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies VRN110755 for egfr-mutant non-small cell lung cancer.
Treatment: VRN110755 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating mutation
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
Required: EGFR resistant mutation
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
Required: EGFR uncommon mutation
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
Required: EGFR complex mutation
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
Required: EGFR exon 19 deletion
exon 19 deletion (Del19)
Required: EGFR l858r
L858R
Required: EGFR c797s
C797S
Required: EGFR exon 19 deletion
Phase 1b - Cohort A: NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation
Required: EGFR l858r
Phase 1b - Cohort A: NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation
Required: EGFR c797x
Phase 1b - Cohort A: ...plus a C797X resistance mutation
Required: EGFR common mutation
Phase 1b - Cohort B: Treatment-naïve NSCLC with common EGFR mutations
Required: EGFR atypical or uncommon mutation
Phase 1b - Cohort C: NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations)
Required: EGFR g719x
G719X
Required: EGFR l861q
L861Q
Required: EGFR s768i
S768I
Required: EGFR e709x
E709X
Required: EGFR r776h
R776H
Required: EGFR l747s
L747S
Required: EGFR atypical mutation
Phase 1b - Cohort D: Treatment-naïve NSCLC with atypical EGFR mutations
Excluded: EGFR exon 20 insertion
NSCLC with an EGFR or HER2 exon 20 insertion mutation
Excluded: HER2 (ERBB2) exon 20 insertion
NSCLC with an EGFR or HER2 exon 20 insertion mutation
Excluded: MET amplification
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification
Excluded: HER2 (ERBB2) amplification
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification
Excluded: ALK fusion
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... ALK ... fusion
Excluded: ROS1 fusion
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... ROS1 ... fusion
Excluded: NTRK1 fusion
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... NTRK ... fusion
Excluded: NTRK2 fusion
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... NTRK ... fusion
Excluded: NTRK3 fusion
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... NTRK ... fusion
Excluded: RET fusion
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... RET ... fusion
Excluded: BRAF v600e
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... BRAF V600E
Excluded: KRAS g12x
Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including ... KRAS G12X mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor
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
Must have received: third-generation EGFR tyrosine kinase inhibitor (osimertinib, lazertinib, aumolertinib) — first-line
disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib)
Must have received: systemic therapy
previously treated with at least one systemic therapy, including an EGFR TKI
Lab requirements
Blood counts
Inadequate bone marrow function based on protocol-defined laboratory criteria [excluded]
Kidney function
Inadequate kidney function based on protocol-defined laboratory criteria [excluded]
Liver function
Inadequate liver function based on protocol-defined laboratory criteria [excluded]
Cardiac function
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 [excluded]
Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07699328 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received EGFR tyrosine kinase inhibitor and third-generation EGFR tyrosine kinase inhibitor.
Does this trial require EGFR?
Yes, EGFR activating mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR resistant mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR uncommon mutation is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR exon 20 insertion is an exclusion criterion.
Are patients with ERBB2 alterations eligible?
No. ERBB2 exon 20 insertion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages