A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Phase 1
150
about 1.7 years
18+
17 sites in CA, CO, DC +11
What this study is about
This trial is testing a treatment called NVL-330 for people with advanced or metastatic lung cancer that has changes to the HER2 gene. The goal is to see if it's safe and effective, determine the best dose, and evaluate its potential to fight the cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take NVL-330
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Incidence and severity of Treatment Emergent Adverse Events (TEAEs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D)
Secondary: Duration of Response (DOR), Effect of Food on Maximum Plasma Concentration (Cmax) of NVL-330, Effect of Food on Time of Maximum Concentration (Tmax) of NVL-330, Half-life (t1/2) of NVL-330, Intracranial Duration of Response (IC-DOR), Intracranial Objective Response Rate (IC-ORR), Maximum plasma concentration (Cmax) of NVL-330, Maximum plasma concentration (Cmax- dose normalized) of NVL-330
Oncology