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NCT03974022 · ClinicalTrials.gov registry record · Phase 1
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Dizal Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT03974022: Active Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Dizal Pharmaceuticals.
NCT03974022 is a Phase 1 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Dizal Pharmaceuticals. The registered enrollment target is 315 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03974022, a Phase 1 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Dizal Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Primary Outcome
To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.
Conditions Studied
Interventions
- DRUG Sunvozertinib
Study Locations (20)
Other
- Fundacion Respirar - Consultorios Medicos Dr. Doreski - Cabildo
- CEMIC Centro de Educación Médica e Investigaciones Clínicas - Hospital Universitario sede Saavedra - Ciudad Autónoma Buenos Aires
- Centro Medico Austral OMI - Ciudad Autónoma Buenos Aires
- Diabaid - Ciudad Autónoma Buenos Aires
- Fundacion CENIT Para La Investigacion en Neurociencias - Ciudad Autónoma Buenos Aires
- Instituto Argentino de Diagnositco y Tratamiento S.A. - Ciudad Autónoma Buenos Aires
- Instituto Medico de la Fundacion de Estudios Clínicos - Ciudad Autónoma Buenos Aires
- Centro de Investigación Pergamino SA - Pergamino
California
- University of California, San Diego (UCSD) - Moores Cancer Center - La Jolla
- University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center - Orange
- Innovative Clinical Research Institute, LLC - Whittier
New York
- Northwell Health - Centers for Advanced Medicine - New Hyde Park
- Laura and Isaac Perlmutter Cancer Center - New York
- Icahn School of Medicine at Mount Sinai - New York
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Michigan Center of Medical Research - Farmington Hills
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT03974022 still lists
NCT03974022 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Sunvozertinib is the first listed.
NCT03974022 names 20 study sites across 9 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT03974022 about?
NCT03974022 is a clinical study titled "Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)". This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the l...
What is the current status of trial NCT03974022?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 315 participants. The study started on 2019-07-09. Estimated completion is 2026-12.
What conditions does trial NCT03974022 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT03974022?
The interventions under investigation include: Sunvozertinib (DRUG).
Who is sponsoring clinical trial NCT03974022?
This trial is sponsored by Dizal Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03974022 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03974022's enrollment target sits among peer trials
315 120th of 454 higher than 335 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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