Actively Recruiting
A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)
Led by Dizal Pharmaceuticals · Updated on 2025-12-31
90
Participants Needed
4
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy.
CONDITIONS
Official Title
A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand the trial and provide signed informed consent before screening
- At least 18 years old at the time of consent
- Confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no worsening in last 2 weeks
- Predicted life expectancy of at least 12 weeks
- Brain metastases allowed only if treated, stable for at least 2 weeks, asymptomatic, and no corticosteroid use
- Adequate organ function based on blood counts and liver, kidney, and coagulation tests
- Male patients with female partners must use barrier contraception during study and 6 months after last dose; sperm donation prohibited during this time
- Female patients must use contraception from screening until 6 weeks after last DZD9008 dose or 3 months after last AZD4205 dose, whichever is later; not breastfeeding and negative pregnancy test at screening
- Part A: Patients with any EGFR mutation who progressed on or are intolerant to prior standard therapy
- Part B: Patients with documented EGFR sensitizing mutation, progressed on or intolerant to prior therapy, measurable disease by RECIST 1.1, and willingness to provide tumor tissue for research
You will not qualify if you...
- Prior treatment with onco-immunotherapy within 4 weeks before study drug
- Chemotherapy or other anticancer drugs within 2 weeks before study drug
- Radiotherapy within 2 weeks before study drug or unresolved radiotherapy toxicity
- Use of medications or supplements that strongly affect CYP3A within 2 weeks before study drug
- Avoidance of grapefruit, Seville oranges, and related products 2 weeks before and during study
- Medications that prolong QT interval must be stopped before study drug
- Major surgery within 4 weeks before study drug or planned during study
- Use of investigational drugs within 4 weeks before study drug
- Spinal cord compression or leptomeningeal metastasis
- Recent malignancy within 2 years needing active treatment except certain treated cancers
- Unresolved toxicities above grade 1 from prior therapy (except hair loss)
- Stroke or brain bleeding within 6 months before study drug
- Severe or uncontrolled diseases including uncontrolled hypertension and active bleeding disorders
- Active infections including tuberculosis, herpes, COVID-19, hepatitis B or C, HIV
- Significant heart abnormalities or diseases including prolonged QT interval, arrhythmias, low heart function
- History of certain lung diseases or active immune-related lung conditions
- Poor lung function with FEV1 and DLCO below 60% expected
- Severe nausea, gastrointestinal disease, swallowing problems, or major bowel surgery
- Receipt of live vaccines within 2 weeks before study drug
- Pregnant or breastfeeding women
- Staff involved in study planning or conduct
- Investigator judgment of inability to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Guangdong Provincial People'S Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China
Completed
3
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Completed
4
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
X
Xindi Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here