Comparing 5 approaches for EGFR-mutant non-small cell lung cancer

Exclusion

• −Known allergy or hypersensitivity to VRN110755 or any of its components.
• −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.
• −Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection.
• −Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.
• −Unresolved side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more → from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.
• −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 protocolProtocolThe detailed plan a study must follow.Read more →-defined laboratory criteria.
• −Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.
• −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 periodWashout periodA gap with no treatment, so the previous one clears your system.Read more →.
• −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.
• −Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.
• −Pregnant or breastfeeding, or planning to become pregnant during the study.
• −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.
• −For Phase 1b and Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → 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.