🏛️ Verified NIH Record • Updated 2026-01-13

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (NCT03974022)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Dizal Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (16 items).

Location: University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • For part B: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment with currently approved EGFR TKIs for sensitizing or T790M resistance mutations, such as gefitinib, erlotinib, osimertinib, afatinib and dacomitinib, are allowed unless the patient had an objective response and subsequent progression assessed by the investigator.
  • Treatment with EGFR or HER2 antibodies, major surgery (excluding placement of vascular access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4) within 4 weeks before the first administration of Sunvozertinib.
  • Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before the first administration.
  • Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before the first administration.
  • Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A within 1-2 weeks before the first administration.
  • Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting Sunvozertinib with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
  • Spinal cord compression or leptomeningeal metastasis.
  • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19 (per local practice).
  • Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs); (2) Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \> 250 msec. (3) Any factors that increase the risk of QTF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval; (4) Prior history of atrial fibrillation within 6 months of first administration of Sunvozertinib, except prior drug treatment related and recovered.
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (124 Sites)

Showing the first 25 of 124 sites.

  • University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California
  • University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center — Orange, California
  • Innovative Clinical Research Institute, LLC — Whittier, California
  • University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado
  • H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • Michigan Center of Medical Research — Farmington Hills, Michigan
  • Northwell Health - Centers for Advanced Medicine — New Hyde Park, New York
  • Laura and Isaac Perlmutter Cancer Center — New York, New York
  • Icahn School of Medicine at Mount Sinai — New York, New York
  • The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
  • Virginia Cancer Specialists — Fairfax, Virginia
  • 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,
  • Clinica Viedma S.A — Viedma,
  • Blacktown Hospital — Blacktown,
  • Chris O'Brien Lifehouse — Camperdown,
  • Austin Hospital — Heidelberg,
  • St George Hospital — Kogarah,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗