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New treatment option for EGFR-Mutant Non-Small Cell Lung Cancer
Official title A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07699328
What this study is testing
What is VRN110755?
VRN110755 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for egfr-mutant non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
- 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...
- Phase 1b - Cohort D
- Treatment-naïve NSCLC with atypical EGFR mutations.
What rules you out
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bedford Park, South Australia, Australia
- Clayton, Victoria, Australia
- Toronto, Ontario, Canada
- Marseille, Bouches-du-Rhône, France
- Dijon, Côte-d'Or, France
- Hong Kong, Hong Kong
- Kuching, Sarawak, Malaysia
- Kuala Lumpur, Malaysia
- Putrajaya, Malaysia
- Singapore, Singapore
- Seongnam-si, Gyeonggi-do, South Korea
- Suwon, Gyeonggi-do, South Korea
- Cheongju-si, North Chungcheong, South Korea
- Seoul, South Korea
- Badalona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
- Kaohsiung City, Taiwan
- Taichung, Taiwan
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bedford Park, South Australia, Australia; Clayton, Victoria, Australia; Toronto, Ontario, Canada; Marseille, Bouches-du-Rhône, France; Dijon, Côte-d'Or, France; Hong Kong, Hong Kong and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.