Non Small Cell Lung CancerWU-KONG15NCT05559645
Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)
A study testing DZD9008 in people with Non Small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2021to 30 Jun 2027
- Phase
- Interventional
- 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
- To provide a signed and dated, written informed consent.
- Aged ≥ 18 years old
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR mutations from a local laboratory
- ECOG performance status 0-1.
- Predicted life expectancy ≥ 12 weeks
- Patient must have measurable disease according to RECIST 1.1.
Show all 17Show fewer
- Patient who has progressed or intolerant to standard therapy (except treatment naïve patients in Cohort 4 and Cohort 7: with EGFR Exon20ins; in Cohort 5 with EGFR sensitizing mutation; and in Cohort8 with EGFR PACC mutation).
- Patients with brain metastasis (BM) can be enrolled under the condition that BM is stable, neurologically asymptomatic and does not require corticosteroid treatment.
- Adequate organ system function.
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/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 metastases or ≤ 5 x ULN with liver metastases
- Creatinine ≤ 1.5 x ULN, concurrent with calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method or ≥ 50 mL/min in 24 hours
- 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
Who cannot join
- Known history of bleeding diathesis.
- Prior malignancy within 2 years requires active treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of first administration.
- History of stroke or intracranial haemorrhage within 6 months before the first administration.
- Spinal cord compression or leptomeningeal metastasis.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Show all 17Show fewer
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs);
- 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 QTcF 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 within 6 months of first administration of DZD9008, except prior drug treatment related and recovered.
- 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.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of DZD9008.
- History of hypersensitivity to active or inactive excipients of DZD9008 or drugs with a similar chemical structure or class to DZD9008.
- Women who are pregnant or breast feeding.
- Involvement in the planning and conduct of the study.
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan Xu, Dr., 8601069155154, maraxu@163.com
Mengzhao Wang
About this study
Official title: DZD9008 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutations: Cohort Study
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
- Non Small Cell Lung Cancer
- Being tested
- DZD9008
- 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.
DZD9008Drug
Daily dosing of DZD9008 200mg
DZD9008Drug
Daily dosing of DZD9008 300mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: EGFR sensitizing mutations, T790M neg | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 2: EGFR sensitizing mutations | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 3: EGFR uncommon mutations | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 4: EGFR Exon20ins | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 5: EGFR sensitizing mutations | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 6: EGFR sensitizing mutations,T790M pos | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 7: EGFR Exon20ins treatment naive | Experimental | Not described Receives: Drug: DZD9008 |
| Cohort 8: treatment-naïve advanced or metastatic NSCLC harbouring EGFR PACC mutations | Experimental | Not described Receives: Drug: DZD9008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To assess anti-tumor activity of DZD9008 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Duration of Response (DoR)
To assess anti-tumor activity of DZD9008 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start18 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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 Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Wang mengzhao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559645
- Sponsor's protocol ID
- DZ2021E0006
- Acronym
- WU-KONG15
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2022
- Last updated
- 2 Sep 2026
- Results posted
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DZD9008 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutations: Cohort Study
- ClinicalTrials.gov ID
- NCT05559645
- Acronym / sponsor ID
- WU-KONG15 / DZ2021E0006
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Sep 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: EGFR sensitizing mutations, T790M neg | Experimental | Drug: DZD9008 |
| Cohort 2: EGFR sensitizing mutations | Experimental | Drug: DZD9008 |
| Cohort 3: EGFR uncommon mutations | Experimental | Drug: DZD9008 |
| Cohort 4: EGFR Exon20ins | Experimental | Drug: DZD9008 |
| Cohort 5: EGFR sensitizing mutations | Experimental | Drug: DZD9008 |
| Cohort 6: EGFR sensitizing mutations,T790M pos | Experimental | Drug: DZD9008 |
| Cohort 7: EGFR Exon20ins treatment naive | Experimental | Drug: DZD9008 |
| Cohort 8: treatment-naïve advanced or metastatic NSCLC harbouring EGFR PACC mutations | Experimental | Drug: DZD9008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- To provide a signed and dated, written informed consent.
- Aged ≥ 18 years old
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR mutations from a local laboratory
- ECOG performance status 0-1.
- Predicted life expectancy ≥ 12 weeks
Key exclusion criteria (17 listed)
- Known history of bleeding diathesis.
- Prior malignancy within 2 years requires active treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of first administration.
- History of stroke or intracranial haemorrhage within 6 months before the first administration.
- Spinal cord compression or leptomeningeal metastasis.
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 |
|---|---|---|
| DZD9008Daily dosing of DZD9008 200mg | Drug | Cohort 1: EGFR sensitizing mutations, T790M neg, Cohort 2: EGFR sensitizing mutations, Cohort 3: EGFR uncommon mutations, Cohort 4: EGFR Exon20ins, Cohort 5: EGFR sensitizing mutations, Cohort 6: EGFR sensitizing mutations,T790M pos, Cohort 8: treatment-naïve advanced or metastatic NSCLC harbouring EGFR PACC mutations |
| DZD9008Daily dosing of DZD9008 300mg | Drug | Cohort 7: EGFR Exon20ins treatment naive, Cohort 8: treatment-naïve advanced or metastatic NSCLC harbouring EGFR PACC mutations |
Primary outcome
Progression-free survival (PFS)
Time frame: through study completion, an average of 1 year
To assess anti-tumor activity of DZD9008 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator
1 secondary outcome
Duration of Response (DoR)
Time frame: through study completion, an average of 1 year
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 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DZD9008 in people with Non Small Cell Lung Cancer, run by Peking Union Medical College Hospital 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 17 inclusion and 17 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 2 Sep 2026. 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.
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 Yan Xu, Dr. (010-69155039, maraxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: through study completion, an average of 1 year). 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 2 Sep 2026.