Study on Oral EGFR Inhibitor Sunvozertinib for Advanced Non-Small Cell Lung Cancer with EGFR or HER2 Mutation
Sponsor: Dizal Pharmaceuticals
ClinicalTrials ID:NCT03974022
This clinical trial is testing a new oral medication, Sunvozertinib, for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations (EGFR or HER2) and has progressed after previous treatments. The study aims to understand the side effects, how the drug behaves in the body, and its effectiveness in treating cancer.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called Sunvozertinib in patients with advanced non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR or HER2 genes. This is the first time Sunvozertinib is being tested in humans, and researchers want to learn about any potential side effects, how the drug is processed in the body, and its ability to fight cancer when used alone.
Description
This study is divided into two phases: Phase I and Phase II. It is an open-label, multicenter trial, meaning that both the researchers and participants know what treatment is being given, and it is conducted at multiple locations. The study will assess the safety, tolerability, and anti-cancer effects of Sunvozertinib in patients with advanced NSCLC that has EGFR or HER2 mutations. The study includes different parts: dose escalation, dose expansion, food effect (Part A), and dose extension (Part B).
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old and able to provide written consent.
- Have a confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 12 weeks.
- Must have measurable disease according to standard criteria.
- Patients with stable brain metastases that do not require steroid treatment can participate.
- Must have adequate organ function.
- For Part A: Patients with EGFR Exon20ins mutation who have not received prior systemic therapy.
- For Part B: Patients with EGFR Exon20ins mutation who have received 1 to 3 lines of prior therapy for advanced disease.
Exclusion Criteria
- For Part B: Patients who have previously been treated with certain EGFR/HER2 inhibitors like Poziotinib or TAK788.
- Recent treatment with EGFR or HER2 antibodies, major surgery, or certain immunotherapies within 4 weeks before starting Sunvozertinib.
- Recent chemotherapy or participation in another clinical study within 14 days before starting Sunvozertinib.
- Recent radiotherapy within 1 to 4 weeks before starting Sunvozertinib.
- Use of certain medications or supplements that affect liver enzymes within 1-2 weeks before starting Sunvozertinib.
- Unresolved side effects from previous treatments, except for hair loss and mild nerve damage.
- Spinal cord compression or cancer spread to the brain lining.
- Severe or uncontrolled diseases or active infections like hepatitis or HIV.
- Certain heart conditions or history of heart rhythm problems.
- History of lung diseases that required steroid treatment.
- Severe digestive issues that affect drug absorption.
- Allergy to Sunvozertinib or similar drugs.
- Pregnant or breastfeeding women.
- Involvement in the study's planning or conduct.
- Any reason the investigator believes the patient should not participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Diego (UCSD) - Moores Cancer Center | 92093 | La Jolla | California |
| University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Innovative Clinical Research Institute, LLC | 90603-2137 | Whittier | California |
| University of Colorado Hospital - Anschutz Cancer Pavilion | 80045 | Aurora | Colorado |
| H. Lee Moffitt Cancer Center & Research Institute | 33612 | Tampa | Florida |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Michigan Center of Medical Research | 48334 | Farmington Hills | Michigan |
| Northwell Health - Centers for Advanced Medicine | 11042-1118 | New Hyde Park | New York |
| Laura and Isaac Perlmutter Cancer Center | 10016 | New York | New York |
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
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