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Non-Small Cell Lung CancerPhase 2NCT05712902

Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)

A Phase 2 study testing Sunvozertinib in people with Non-Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 33 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase II, single-arm, multi-center clinical study to evaluate the anti-tumor efficacy, safety, tolerability and pharmacokinetics of Sunvozertinib in participants with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease has progressed on prior platinum-based… 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?
Sunvozertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
33 sitesChina
Study dates
19 Jul 2021to 31 Dec 2025
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 be able to understand the nature of the trial and provide a signed and dated, written informed consent form.
  • Aged at least 18 years old.
  • Histological or cytological confirmed locally advanced or metastatic NSCLC
  • Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laboratories.
  • Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the past 2 weeks.
  • Predicted life expectancy ≥ 12 weeks.
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  • Patient must have measurable disease according to RECIST 1.1.
  • Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable.
  • Adequate organ system functions.
  • Patients should receive at least one line but no more than three lines of prior systemic therapy (at least one line must contain platinum-based therapy).

Who cannot join

  • Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer types (to be discussed with Dizal's Study Physician) who 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 Sunvozertinib with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
  • Spinal cord compression or leptomeningeal metastasis.
  • History of stroke or intracranial hemorrhage within 6 months before first administration of Sunvozertinib.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.
  • Active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19.
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  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc) > 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 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 within 6 months of first administration of Sunvozertinib, except prior drug treatment related and recovered.
  • Participants with hemorrhagic diseases such as von Willebrand disease.
  • 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 or immunotherapy induced immune pneumonia.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib.
  • Prior/concomitant therapy
  • Patients who have received prior Poziotinib, TAK-788, CLN-081 or BDTX-189, furmonertinib or any other EGFR/HER2 exon20ins small molecule inhibitors treatment should be excluded.
  • Other EGFR TKIs, such as gefitinib, erlotinib, osimertinib, afatinib, dacomitinb are not considered EGFR or HER2 Exon20ins small molecule inhibitors, and thus prior treatment with these drugs is allowed unless the patient had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.
  • Treatment with antibodies within 4 weeks before first administration of Sunvozertinib.
  • Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before first administration of Sunvozertinib.
  • Women who are pregnant or breast feeding.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Chest Hospital，Capital Medical University

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Army Medical Center of PLA

    Chongqing

  • Chongqing University Cancer Hospital(Chongqing Cancer Hospital)

    Chongqing

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Hainan General Hospital

    Haikou

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital (Cancer Hospital of the University of Chinese Academy of Sciences)

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • The Second Hospital of Anhui Medical University

    Hefei

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

  • Jinan Central Hospital (Central Hospital Affiliated to Shandong First Medical University)

    Jinan

  • Yunnan Cancer Hospital

    Kunming

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Fudan University Shanghai Cancer Center

    Shanghai

  • The First Hospital of China Medical University

    Shenyang

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Shanxi Provincial Cancer Hospital

    Taiyuan

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi

  • Hubei Cancer Hospital

    Wuhan

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Affiliated Cancer Hospital of Zhengzhou University(Henan Cancer Hospital)

    Zhengzhou

Other trials in China

About this study

Official title: A Phase II, Single Arm, Multicenter Study to Evaluate Anti-tumor Activity, Safety, Tolerability and Pharmacokinetics of DZD9008 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation

This is a Phase II, single-arm, multi-center clinical study to evaluate the anti-tumor efficacy, safety, tolerability and pharmacokinetics of Sunvozertinib in participants with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease has progressed on prior platinum-based chemotherapy

Being tested
Sunvozertinib
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.

  • SunvozertinibDrug

    Also called DZD9008

    Daily dose of Sunvozertinib

Study groups in NCT05712902
Study groupRoleWhat they receive
Daily dose of SunvozertinibExperimentalNot described
Receives: Drug: Sunvozertinib

What is being measured

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

  1. Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC)

    Measured: From first dosing until disease progression or intolerable adverse events

Timeline

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

  1. First posted6 Feb 2023
  2. Study start19 Jul 2021
  3. Primary completion17 Oct 2022
  4. Study completion31 Dec 2025 (estimated)

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
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05712902
Sponsor's protocol ID
DZ2020E0001
Status last verified
Dec 2024
First submitted
12 Jan 2023
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, Hu Y, Han Z, Song X, Liu A, Tang K, Ding C, Liang L, Wu L, Gao J, Wang J, Cheng Y, Zhou J, He Y, Dong X, Yao Y, Yu Y, Wang H, Sun S, Huang J, Fang J, Li W, Wang L, Ren X, Zhou C, Hu Y, Zhao D, Yang R, Xu F, Huang Y, Pan Y, Cui J, Xu Y, Yang Z, Shi Y. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial. Lancet Respir Med. 2024 Mar;12(3):217-224. doi: 10.1016/S2213-2600(23)00379-X. Epub 2023 Dec 12.

    PubMed 38101437

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunvozertinib in people with Non-Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 33 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 10 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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?

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?

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?

Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC) (time frame: From first dosing until disease progression or intolerable adverse events). 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 NCT05712902, which also lists 1 linked publication.

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 30 Dec 2024.

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