Actively Recruiting
DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)
Led by Dizal Pharmaceuticals · Updated on 2025-06-19
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab.
CONDITIONS
Official Title
DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the trial and provide informed consent before any study procedures
- Age 18 years or older
- Confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer
- Documented EGFR mutations; Part A includes any EGFR mutation, Part B includes only EGFR Exon 20 insertion mutation
- ECOG score of 0 or 1 with no significant disease worsening in the last 2 weeks and life expectancy of at least 12 weeks
- Stable brain metastases without progression for at least 2 weeks, no neurological symptoms, and no need for steroids
- For Part A, progressed after or unable to tolerate standard care
- For Part B, progressed after or unable to tolerate standard care; treatment-naive patients allowed after safety evaluation
- Measurable lesions per RECIST 1.1, at least one lesion ≥10 mm (or lymph nodes ≥15 mm) suitable for accurate measurement
- Male participants with female partners or fertility desire agree to use barrier contraception until 6 months after last dose and avoid sperm donation; sperm freezing suggested
- Female participants agree to use effective contraception, are not breastfeeding, and have negative pregnancy tests or meet post-menopausal or surgical sterilization criteria
You will not qualify if you...
- Prior treatment with specific EGFR Exon 20 insertion inhibitors before study drug (Part B only)
- Prior treatment with 1st to 3rd generation EGFR-TKIs with objective response (Part B only)
- Prior systemic treatment for locally advanced/metastatic NSCLC in treatment-naive patients (Part B only)
- EGFR, HER2, or VEGFR antibody treatment within 4 weeks before study drug
- Chemotherapy or other anti-tumor therapy within 2 weeks before study drug
- Radiotherapy within 14 days before study drug or unresolved radiotherapy toxicities, except certain palliative radiotherapies
- Medications or herbal supplements affecting CYP3A4 within 1-2 weeks before study drug
- Major surgery within 4 weeks before study drug or expected during study
- Treatment with investigational drugs within 5 half-lives before study drug
- Spinal cord compression or leptomeningeal metastasis
- Concurrent EGFR mutations with approved EGFR-TKIs (Part B only)
- History of malignancy within 2 years except certain skin or cervical cancers
- Unresolved toxicities > grade 1 from prior therapies except alopecia and grade 2 neuropathy
- Stroke or intracranial hemorrhage within 6 months
- Severe or uncontrolled systemic diseases including uncontrolled hypertension and active bleeding disorders
- Active infections including hepatitis B, C, HIV, or COVID-19
- Cardiac abnormalities such as QT prolongation, significant arrhythmias, or recent myocardial infarction
- History of interstitial lung disease or immune-related pneumonitis
- Severe nausea, vomiting, swallowing difficulties, or previous bowel surgery affecting drug absorption
- Inadequate bone marrow or organ function as defined by blood counts and lab values
- Live virus vaccine within 2 weeks before study drug
- Pregnancy or breastfeeding
- Contraindications to bevacizumab including severe blood clots, uncontrolled hypertension, bleeding disorders, major vessel invasion, recent hemorrhage, or gastrointestinal perforation
- Severe allergic reactions to study drugs or excipients
- Involvement in study design or conduct
- Poor compliance or inability to participate as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Y
Yiman Wang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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