Actively Recruiting
Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)
Led by Peking Union Medical College Hospital · Updated on 2024-05-29
180
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
D
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single center cohort study to access the anti-tumor efficacy, safety and tolerability of DZD9008 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations and EGFR uncommon mutations who have progressed following standard TKI therapy, and in treatment naive patients with NSCLC harboring EGFR Exon20 insertion mutation and EGFR sensitizing mutations.
CONDITIONS
Official Title
Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Age 18 years or older
- Confirmed locally advanced or metastatic NSCLC with EGFR mutations
- ECOG performance status of 0 or 1
- Predicted life expectancy of at least 12 weeks
- Measurable disease based on RECIST 1.1 criteria
- Progressed on or intolerant to standard therapy (except treatment naive patients in specific cohorts with EGFR Exon20ins or sensitizing mutations)
- Stable brain metastases without neurological symptoms and no need for corticosteroids
- Adequate organ function including:
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN with Gilbert's Syndrome or liver metastases)
- ALT and AST ≤ 2.5 x ULN (or ≤ 5 x ULN with liver metastases)
- Creatinine ≤ 1.5 x ULN and creatinine clearance ≥ 50 mL/min
- INR ≤ 1.5 x ULN and APTT ≤ 1.5 x ULN
- Serum amylase and lipase ≤ 1.5 x ULN
You will not qualify if you...
- History of bleeding disorders
- Prior cancer requiring active treatment within 2 years
- Unresolved toxicities from previous treatments greater than grade 1
- Stroke or brain bleeding within 6 months before starting study drug
- Spinal cord compression or leptomeningeal metastasis
- Severe or uncontrolled systemic diseases or active infections including hepatitis B, hepatitis C, or HIV
- Cardiac issues such as:
- QTcF interval > 470 msec
- Significant ECG abnormalities (e.g., complete left bundle branch block, high-degree heart block)
- Risk factors for QT prolongation like heart failure or family history of sudden death
- Atrial fibrillation within 6 months (except drug-related and recovered cases)
- History of interstitial lung disease or related lung conditions needing steroid treatment
- Severe nausea, vomiting, gastrointestinal diseases, swallowing problems, or bowel surgery affecting drug absorption
- Allergies to DZD9008 or similar drugs
- Pregnant or breastfeeding women
- Involvement in study planning or conduct
- Investigator judgment that patient is unlikely to comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yan Xu, Dr.
CONTACT
M
Mengzhao Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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