Non-small Cell Lung CancerPhase 2NCT06276283
DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)
A Phase 2 study testing DZD9008 plus Bevacizumab in people with Non-small Cell Lung Cancer, run by Dizal Pharmaceuticals at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- DZD9008 plus Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following criteria for inclusion in the study:
- Sufficient understanding of nature of the trial and provision of informed consent with hand-written signatures and the date of signature prior to any study-specific procedures, sampling, and analyses.
- Age ≥ 18 years.
- Histologically or cytologically confirmed and locally advanced or metastatic non-squamous NSCLC.
- Written documentation of EGFR mutations from an accredited local laboratory: Part A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.
- ECOG score ≤ 1 without clinically significant disease deterioration within 2 weeks prior to the informed consent process and a life expectancy ≥ 12 weeks.
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- Patients with stable brain metastasis provided no evidence of progression for at least 2 weeks, as ascertained by brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the screening period, no neurological symptoms, and no requirement of Steroids.
- Part A includes patients who have progressed after or cannot tolerate the standard of care
- Part B includes patients with NSCLC who have progressed after or cannot tolerate standard of care. Treatment naïve patients will be enrolled after an adequate evaluation of the safety data by the Safety Review Committee (Note: Patients who have received (neo)adjuvant therapy are allowed to participate in the study, if the (neo)adjuvant therapy is administrated at least 6 months prior to the diagnosis of locally advanced or metastatic NSCLC) .
- Measurable lesions, according to RECIST 1.1: at least one lesion, not previous irradiated, with the longest diameter ≥ 10 mm at baseline (lymph nodes must have a short axis of ≥ 15 mm), that can be accurately measured at baseline and thereafter with MRI or CT scan.
- Male patients with a female partner or fertility desire should be willing to use barrier contraception (e.g., condoms) until 6 months after the last dose. Male patients should not donate sperms until 6 months after the last dose. Male patients with fertility desire are suggested to freeze their sperm before entering the study.
- Female patients should be willing to use adequate contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test (i.e., urine and blood pregnancy human chorionic gonadotropin testing); or female patients meet the following criteria:
- Post-menopausal defined as age more than 60 and amenorrheic for at least 12 months after all exogenous hormonal treatments.
- Women under 60 years old would be considered post-menopausal if they have been amenorrheic for at least 12 months with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
- Documentation of irreversible surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation).
Who cannot join
- Patients must not enter the study if any of the following exclusion criteria are met:
- Treatment with any of the following:
- Treatment with poziotinib, mobocertinib (TAK788), CLN-081, BDTX-189, aumolertinib, AP-L1898, and other EGFR Exon20ins inhibitors prior to the first dose of study drug (only applicable to Part B).
- Prior treatment with 1st to 3rd generation EGFR-TKIs (e.g., gefitinib, erlotinib, icotinib, osimertinib, afatinib, dacomitinib, and ametinib) and have had an objective response (i.e., PR and CR) (only applicable to Part B).
- Prior systemic treatment for locally advanced or metastatic NSCLC (only applicable to treatment naïve patients in Part B)
- Treatment with EGFR, HER2, or VEGFR antibody within 4 weeks of the first dose of study drug.
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- Chemotherapy or other anti-tumor therapies within 2 weeks of the first dose of study drug.
- Radiotherapy within 14 days of the first dose of study drug or unresolved radiotherapy-related toxicities. Patients could receive palliative radiotherapy for tumor lesions outside of brain and chest, stereotactic radiosurgery, and stereotactic body radiotherapy.
- Current treatment within 1-2 weeks of the first dose of study drug with medications or herbal supplements known to be potent inhibitors (1 week) or inducers (2 weeks) of cytochrome P450 (CYP) 3A4.
- Major surgery, excluding biopsy and diagnostic surgery, within 4 weeks of the dose of study drug, or expected major surgeries during the study period.
- Treatment with an investigational drug within 5 half-lives of the compound. Patient
- Spinal cord compression or leptomeningeal metastasis.
- Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).
- History of malignancy within 2 years of the first dose of study drug (excluding adequately treated Basal cell carcinoma or in situ cervical cancer with a tumor-free period of more than 2 years and a life expectancy of more than 2 years. The inclusion of such patients should be discussed with the study physician from Dizal Pharma).
- Any unresolved toxicities from prior systemic therapy (e.g., adjuvant chemotherapy and radiotherapy) > CTCAE grade 1 at the time of starting study drug except for alopecia and grade 2 neuropathy related to previous platinum-based therapy.
- History of stroke and intracranial hemorrhage within 6 months of the first dose of study drug.
- Any evidence of severe or uncontrolled systematic disease based on the investigator's opinion, including uncontrolled hypertension and active bleeding diatheses (e.g., hemophilia and von Willebrand disease).
- Any evidence of active infection, including but not limited to hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and COVID-19. The diagnosis of COVID-19 follows the local practice.
- Test Include if Exclude if HIV antibody (-) (+) HCV antibody (-) (+) HBV antibody HbsAg (-) and HbcAb (-) HbsAg (+) and HBV DNA ≥ 1000 IU/mL HbsAg (-), HbcAb (+) and HBV DNA < 1000 IU/mL HbsAg (-), HbcAb (+), and HBV DNA ≥ 1000 IU/mL (-), Negative; (+), Positive.
- Any of the following cardiac events or abnormalities:
- Mean resting corrected QT interval (QTcF) > 470 msec.
- Any clinically significant abnormalities in rhythm, conduction, or morphology detected by resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, and PR interval > 250 msec.
- Any factors that can lead to QTcF prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, family history of unexplained sudden death under 40 years of age, or any comorbidities known to prolong the QT interval.
- Any evidence of atrial fibrillation (except for drug-related atrial fibrillation that has been resolved after drug discontinuation).
- Any evidence of myocadiac infraction, congestive heart failure (New York Heart Association Class II or above), and uncontrolled arrhythmia with medication within 6 months of the first dose of study drug.
- History of interstitial lung disease (ILD), drug-induced ILD, and immune-related pneumonitis due to cancer immunotherapy.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing the study drug, or previous bowel resection that would preclude adequate absorption of DZD9008.
- Inadequate bone marrow reserve or organ function:
- Absolute neutrophil count < 1.5 × 109/L
- Platelet count < 100 ×109/L
- Hemoglobin < 9 g/dL
- Total bilirubin >1.5 × ULN if no liver metastases or >3 × the upper limit of normal (ULN) in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST >2.5 × ULN if no demonstrable liver metastases or >5 × ULN in the presence of liver metastases.
- Creatinine ≥1.5 × ULN or creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation)
- The international normalized ratio > 1.5 × ULN and activated partial thromboplastin time (APTT) > 1.5 × ULN
- Serum lipase) > 1.5 × ULN and serum amylase > 1.5 × ULN
- Live virus vaccines administrated within 2 weeks of the first dose of study drug.
- Pregnant women or women who are breastfeeding.
- Concurrent contraindications to bevacizumab, including but not limited to:
- Deep vein thrombosis ≥ CTCAE grade 3
- Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
- Intracerebral hemorrhage, including hemorrhage caused by metastatic brain tumors.
- History of severe proteinuria (urine dipstick protein 2+ or 24-hour urine protein > 2g)
- History of hypertensive crisis and hypertensive encephalopathy
- History of central nervous system diseases that are not related to the tumor (e.g., convulsions)
- History of vascular events within 6 months of the first dose of study drug (e.g., aneurysm requiring treatment)
- History of hemoptysis within 3 months of the first dose of study drug (two spoonfuls of blood each time)
- History of bleeding disorders or coagulation disorders without treatment of anticoagulants.
- Tumor invasion of major vessels
- History of gastrointestinal perforation or fistula within 6 months of the first dose of study drug
- Severe allergic reaction to DZD9008, bevacizumab, or their excipients.
- Subjects who are involved in the design, planning, or conduct of the study (applicable to employees of Dizal Pharm and staff at investigational sites).
- Poor compliance or inability to participate in clinical studies according to the investigator's assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Lu, Dr
About this study
Official title: A Phase II, Single Arm, Multicenter Study to Assess the Safety, Tolerability and Anti-Tumor Efficacy of DZD9008 With Bevacizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Mutations (WU-KONG29)
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.
Read the detailed description
A phase 2, multicenter study to evaluate the safety, tolerability, and anti-tumor efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR mutations. This study comprises two parts (Part A, dose escalation and Part B, dose expansion). Part A will enroll patients with different EGFR mutations. Only patients with EGFR Exon 20 insertion mutation will be enrolled into Part B.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- DZD9008 plus Bevacizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD9008 plus BevacizumabDrug
Also called Inapplicable
DZD9008, 200 mg or 300 mg, once daily plus Bevacizumab 15 mg/kg, once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| DZD9008 plus Bevacizumab | Experimental | This single-arm study includes two parts (dose escalation [Part A] and dose expansion [Part B]). Receives: Drug: DZD9008 plus Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs.
To investigate the safety and tolerability of DZD9008 in combination with Bevacizumab in patients with locally advanced NSCLC harboring EGFR mutations. Part A is a dose escalation study to determine the recommended phase 2 combination dose of DZD9008 and Bevacizumab. Part B is a dose expansion study to further investigate the safety and tolerability of the combination therapy at the recommended phase 2 combination dose.
Measured: The first treatment cycle (each cycle is 21 days) for DLT; From the first dose of study treatment to 28 days after the last dose of study treatment for TEAE; and from ICF signature to 28 days after the last dose of study treatment for SAE.
Secondary outcomes (1)
Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite.
To investigate the anti-tumor efficacy of DZD9008 in combination with Bevacizumab and the pharmacokinetics of DZD9008 and its metabolite DZ0753 when given in combination with Bevacizumab. The efficacy endpoints per RECIST 1.1 include Objective Response Rate (ORR), Duration of Response (DoR),Disease Control Rate (DCR), and Progression Free Survival (PFS).
Measured: From the first dose of study treatment to disease progression, death or study withdrawal, whichever occurs first; and Cycle 1/3/5/7 day 1 (each cycle is 21 days) for plasma concentration of DZD9008 and its metabolite.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start15 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276283
- Sponsor's protocol ID
- DZ2022E0006
- Status last verified
- Jun 2025
- First submitted
- 7 Feb 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Arm, Multicenter Study to Assess the Safety, Tolerability and Anti-Tumor Efficacy of DZD9008 With Bevacizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Mutations (WU-KONG29)
- ClinicalTrials.gov ID
- NCT06276283
- Acronym / sponsor ID
- DZ2022E0006
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A phase 2, multicenter study to evaluate the safety, tolerability, and anti-tumor efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR mutations. This study comprises two parts (Part A, dose escalation and Part B, dose expansion). Part A will enroll patients with different EGFR mutations. Only patients with EGFR Exon 20 insertion mutation will be enrolled into Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DZD9008 plus Bevacizumab | Experimental | Drug: DZD9008 plus BevacizumabThis single-arm study includes two parts (dose escalation [Part A] and dose expansion [Part B]). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sufficient understanding of nature of the trial and provision of informed consent with hand-written signatures and the date of signature prior to any study-specific procedures, sampling, and analyses.
- Age ≥ 18 years.
- Histologically or cytologically confirmed and locally advanced or metastatic non-squamous NSCLC.
- Written documentation of EGFR mutations from an accredited local laboratory: Part A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.
- ECOG score ≤ 1 without clinically significant disease deterioration within 2 weeks prior to the informed consent process and a life expectancy ≥ 12 weeks.
Key exclusion criteria (53 listed)
- Treatment with any of the following:
- Spinal cord compression or leptomeningeal metastasis.
- Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).
- History of malignancy within 2 years of the first dose of study drug (excluding adequately treated Basal cell carcinoma or in situ cervical cancer with a tumor-free period of more than 2 years and a life expectancy of more than 2 years. The inclusion of such patients should be discussed with the study physician from Dizal Pharma).
- Any unresolved toxicities from prior systemic therapy (e.g., adjuvant chemotherapy and radiotherapy) > CTCAE grade 1 at the time of starting study drug except for alopecia and grade 2 neuropathy related to previous platinum-based therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD9008 plus BevacizumabAlso: InapplicableDZD9008, 200 mg or 300 mg, once daily plus Bevacizumab 15 mg/kg, once every 3 weeks | Drug | DZD9008 plus Bevacizumab |
Primary outcome
Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs.
Time frame: The first treatment cycle (each cycle is 21 days) for DLT; From the first dose of study treatment to 28 days after the last dose of study treatment for TEAE; and from ICF signature to 28 days after the last dose of study treatment for SAE.
To investigate the safety and tolerability of DZD9008 in combination with Bevacizumab in patients with locally advanced NSCLC harboring EGFR mutations. Part A is a dose escalation study to determine the recommended phase 2 combination dose of DZD9008 and Bevacizumab. Part B is a dose expansion study to further investigate the safety and tolerability of the combination therapy at the recommended phase 2 combination dose.
1 secondary outcome
Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite.
Time frame: From the first dose of study treatment to disease progression, death or study withdrawal, whichever occurs first; and Cycle 1/3/5/7 day 1 (each cycle is 21 days) for plasma concentration of DZD9008 and its metabolite.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lu principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DZD9008 plus Bevacizumab in people with Non-small Cell Lung Cancer, run by Dizal Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiman Wang, MD, PhD (+ 86 21 6109 7885, yiman.wang@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs. (time frame: The first treatment cycle (each cycle is 21 days) for DLT; From the first dose of study treatment to 28 days after the last dose of study treatment for TEAE; and from ICF signature to 28 days after the last dose of study treatment for SAE.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.