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Non-small Cell Lung CancerPhase 2NCT06295432

A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)

A Phase 2 study testing DZD9008+AZD4205 in people with Non-small Cell Lung Cancer, run by Dizal Pharmaceuticals at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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+AZD4205
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
4 sitesChina
Study dates
1 Jun 2023to 8 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 be able to understand the nature of the trial and provide a signed and dated informed consent form prior to screening.
  • Aged at least 18 years old when sign ICF.
  • Histological or cytological confirmed locally advanced or metastatic NSCLC.
  • Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the previous 2 weeks.
  • Predicted life expectancy ≥ 12 weeks.
  • Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable e.g. no evidence of progression for at least 2 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance image [MRI] or computed tomography [CT] scan) during the screening period), neurologically asymptomatic and not require corticosteroid treatment.
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  • Adequate organ system functions, as outlined below
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Absolute lymphocyte count ≥ 0.8 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver involvement or ≤ 5 x ULN with liver involvement
  • Creatinine ≤ 1.5 x ULN, or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method
  • International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
  • Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN
  • Male subjects with a female partner who intend to have children should use barrier contraception (e.g. condom) during their participation in the clinical study until 6 months after the last dose. Male subjects should not donate sperm during the clinical study until 6 months after the last dose. If the male subject has fertility requirements, it is recommended that sperm be frozen prior to the start of the clinical study.
  • Female subjects should use contraception at screening until 6 weeks after the last dose of DZD9008 or 3 months after the last dose of AZD4205, whichever is later, should not be breastfeeding and should have a negative pregnancy test (blood or urine β-HCG) at the time of screening.
  • Part A specific inclusion criteria:
  • Subjects should harbour any type of EGFR mutation.
  • Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic/locally advanced disease.
  • Part B specific inclusion criteria:
  • Subjects must have documented EGFR sensitizing mutation from a local certified laboratory.
  • Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic/locally advanced disease.
  • Patient must have measurable disease according to RECIST 1.1: At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for repeated measurement.
  • Agree and be willing to provide an adequate amount of the required tumor tissue for exploratory studies.

Who cannot join

  • Treatment with any of the followings:
  • Prior treatment with any onco-immunotherapy (e.g. PD-1) within 4 weeks before the first administration of IP.
  • Any cytotoxic chemotherapy, or other anticancer drugs from a previous treatment regimen within 2 weeks before the first administration of IP.
  • Radiotherapy within 2 weeks of the first dose or have not recovered from radiotherapy-related toxicity May receive palliative radiotherapy other than chest and brain, stereotactic radiosurgery and stereotactic body radiation therapy within 1 week prior to first dose a limited field of radiation for palliation within 1 week of the first administration of IP.
  • Patients currently receiving (or unable to stop using) medications known to be potent inhibitors or inducers of CYP3A or herbal supplements within 2 weeks before the first administration of IP.
  • Patients should avoid eating food known to be inhibitors of CYP3A such as grapefruit and Seville oranges (and other products containing these fruits, e.g., grapefruit juice or marmalade) within 2 weeks before the first administration of IP and 2 weeks after the therapy.
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  • Drugs that prolong the QT interval need to be discontinued before the start of IP
  • Major surgery (excluding biopsy) within 4 weeks before the first administration of IP, or expect to have major surgery during study.
  • Treatment with any investigational drug (or unable to stop using) within 4 weeks before the first administration of IP
  • Spinal cord compression or leptomeningeal metastasis.
  • Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer type which has been disease free for > 2 years with life expectancy >2 years
  • Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting IP with the exception of alopecia.
  • History of stroke or intracranial haemorrhage within 6 months before the first administration of IP.
  • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (e.g., hemophilia, Von Willebrand disease).
  • Presence of persistent or active infection, including but not limited to:
  • Active or latent tuberculosis
  • Active herpes simplex, herpes zoster infection
  • COVID-19
  • active HBV, HCV, HIV infection
  • Any of the following cardiac abnormal and disease:
  • resting corrected QT interval (QTc) > 470 msec
  • 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
  • Any factors that increase the risk of QTc 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
  • Prior history of atrial fibrillation except prior drug treatment related and recovered
  • Prior history of myocardial infarction, congestive heart failure, arrhythmias that are poorly controlled by medication
  • LVEF < 55% accessed by ECHO
  • 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, immunotherapy-induced immune pneumonitis.
  • Significant pulmonary function impairment (i.e. pulmonary function test showing FEV1 and DLCO < 60% of expected values).
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of IP.
  • Receiving live vaccines within 2 weeks before the first administration of IP.
  • Women who are pregnant or breast feeding.
  • Involvement in the planning and conduct of the study (applies to Dizal staff or staff at the study site).
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Guangdong Provincial People'S Hospital

    Guangzhou, Guangdong, 510000

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Phase II, Multicenter Study to Assess the Safety, Tolerability and Anti-tumor Efficacy of DZD9008 in Combination With AZD4205 in Standard Treatment Failed Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Mutations

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.

Being tested
DZD9008+AZD4205
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+AZD4205Drug

    Also called Inapplicable

    Daily dose of DZD9008+AZD4205 until intolerant, disease progression or patient decision. Starting dose of DZD9008 is 200mg once daily and starting dose of AZD4205 is 75mg once daily orally used. If tolerated, subsequent cohorts will evaluate increasing doses of the combination therapy.

Study groups in NCT06295432
Study groupRoleWhat they receive
DZD9008+AZD4205ExperimentalAll subjects will receive both DZD9008 tablets and AZD4205 capsules orally. DZD9008 dosing will start at 200 mg daily, AZD4205 dosing will start at 75 mg daily.
Receives: Drug: DZD9008+AZD4205

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs.

    Part A: safety and tolerability of the combination therapy: incidence of DLT as defined in the protocol, incidence of ≥grade 3 TEAE as assessed by CTCAE, incidence of SAE; Part B: safety and tolerability of the combination therapy, to define RP2CD: incidence of ≥grade 3 TEAE as assessed by CTCAE, incidence of SAE.

    Measured: DLT: 21 days after the first dose; AE that began after the start of trial medication treatment until 28 days after last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start1 Jun 2023
  3. Primary completion8 Jun 2026
  4. Study completion8 Jun 2026

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295432
Sponsor's protocol ID
DZ2022E0001
Status last verified
Oct 2026
First submitted
7 Feb 2024
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DZD9008+AZD4205 in people with Non-small Cell Lung Cancer, run by Dizal Pharmaceuticals at 4 sites 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 26 inclusion and 33 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs. (time frame: DLT: 21 days after the first dose; AE that began after the start of trial medication treatment until 28 days after last dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295432.

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 22 Oct 2026.

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