Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05668988




Registration number
NCT05668988
Ethics application status
Date submitted
20/12/2022
Date registered
30/12/2022

Titles & IDs
Public title
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Scientific title
A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation
Secondary ID [1] 0 0
DZ2022E0005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sunvozertinib
Treatment: Drugs - Pemetrexed+carboplatin

Experimental: sunvozertinib -

Active comparator: Platinum-based Chemotherapy -


Treatment: Drugs: sunvozertinib
orally, 300 mg, once daily until a treatment discontinuation criterion is met.

Treatment: Drugs: Pemetrexed+carboplatin
Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Timepoint [1] 0 0
Up to approximately 34 months after the first participant is randomized
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to approximately 34 months after the first participant is randomized

Eligibility
Key inclusion criteria
1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy = 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Concord Cancer Centre Medical Oncology Clinical Trials Unit Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital, Heart Research Insititute - Nedlands
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Rosario
Country [11] 0 0
Argentina
State/province [11] 0 0
San Salvador
Country [12] 0 0
Argentina
State/province [12] 0 0
Viedma
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Salzburg
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerp
Country [16] 0 0
Belgium
State/province [16] 0 0
Flanders
Country [17] 0 0
Belgium
State/province [17] 0 0
Hainaut
Country [18] 0 0
Brazil
State/province [18] 0 0
Barretos
Country [19] 0 0
Brazil
State/province [19] 0 0
Cachoeiro De Itapemirim
Country [20] 0 0
Brazil
State/province [20] 0 0
Natal
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
Recife
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio De Janeiro
Country [24] 0 0
Brazil
State/province [24] 0 0
São Paulo
Country [25] 0 0
Canada
State/province [25] 0 0
London
Country [26] 0 0
Canada
State/province [26] 0 0
Ottawa
Country [27] 0 0
Canada
State/province [27] 0 0
Toronto
Country [28] 0 0
China
State/province [28] 0 0
Beijing
Country [29] 0 0
China
State/province [29] 0 0
Changsha
Country [30] 0 0
China
State/province [30] 0 0
Chengdu
Country [31] 0 0
China
State/province [31] 0 0
Chongqing
Country [32] 0 0
China
State/province [32] 0 0
Fuzhou
Country [33] 0 0
China
State/province [33] 0 0
Guangzhou
Country [34] 0 0
China
State/province [34] 0 0
Hangzhou
Country [35] 0 0
China
State/province [35] 0 0
Harbin
Country [36] 0 0
China
State/province [36] 0 0
Hefei
Country [37] 0 0
China
State/province [37] 0 0
Hohhot
Country [38] 0 0
China
State/province [38] 0 0
Jilin
Country [39] 0 0
China
State/province [39] 0 0
Jinan
Country [40] 0 0
China
State/province [40] 0 0
Kunming
Country [41] 0 0
China
State/province [41] 0 0
Nanchang
Country [42] 0 0
China
State/province [42] 0 0
Nanjing
Country [43] 0 0
China
State/province [43] 0 0
Nanning
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
China
State/province [45] 0 0
Shenyang
Country [46] 0 0
China
State/province [46] 0 0
Shenzhen
Country [47] 0 0
China
State/province [47] 0 0
Shijiazhuang
Country [48] 0 0
China
State/province [48] 0 0
Taiyuan
Country [49] 0 0
China
State/province [49] 0 0
Taizhou
Country [50] 0 0
China
State/province [50] 0 0
Tianjin
Country [51] 0 0
China
State/province [51] 0 0
Wuhan
Country [52] 0 0
China
State/province [52] 0 0
Xi'an
Country [53] 0 0
China
State/province [53] 0 0
Yantai
Country [54] 0 0
China
State/province [54] 0 0
Zhengzhou
Country [55] 0 0
Czechia
State/province [55] 0 0
Olomouc
Country [56] 0 0
Czechia
State/province [56] 0 0
Ostrava
Country [57] 0 0
France
State/province [57] 0 0
Angers
Country [58] 0 0
France
State/province [58] 0 0
Bron
Country [59] 0 0
France
State/province [59] 0 0
Créteil
Country [60] 0 0
France
State/province [60] 0 0
Hellemmes-Lille
Country [61] 0 0
France
State/province [61] 0 0
La Tronche
Country [62] 0 0
France
State/province [62] 0 0
Marseille
Country [63] 0 0
France
State/province [63] 0 0
Montpellier
Country [64] 0 0
France
State/province [64] 0 0
Paris
Country [65] 0 0
France
State/province [65] 0 0
Poitiers
Country [66] 0 0
France
State/province [66] 0 0
Saint Herblain
Country [67] 0 0
France
State/province [67] 0 0
Saint-Mande
Country [68] 0 0
France
State/province [68] 0 0
Suresnes
Country [69] 0 0
Germany
State/province [69] 0 0
Berlin
Country [70] 0 0
Germany
State/province [70] 0 0
Gauting
Country [71] 0 0
Germany
State/province [71] 0 0
Georgsmarienhütte
Country [72] 0 0
Germany
State/province [72] 0 0
Heidelberg
Country [73] 0 0
Germany
State/province [73] 0 0
Mainz
Country [74] 0 0
Germany
State/province [74] 0 0
Oldenburg
Country [75] 0 0
Italy
State/province [75] 0 0
Aviano
Country [76] 0 0
Italy
State/province [76] 0 0
Bologna
Country [77] 0 0
Italy
State/province [77] 0 0
Catania
Country [78] 0 0
Italy
State/province [78] 0 0
Florence
Country [79] 0 0
Italy
State/province [79] 0 0
Grosseto
Country [80] 0 0
Italy
State/province [80] 0 0
Meldola
Country [81] 0 0
Italy
State/province [81] 0 0
Modena
Country [82] 0 0
Italy
State/province [82] 0 0
Monza
Country [83] 0 0
Italy
State/province [83] 0 0
Palermo
Country [84] 0 0
Italy
State/province [84] 0 0
Parma
Country [85] 0 0
Italy
State/province [85] 0 0
Ravenna
Country [86] 0 0
Italy
State/province [86] 0 0
Reggio Emilia
Country [87] 0 0
Italy
State/province [87] 0 0
Roma
Country [88] 0 0
Italy
State/province [88] 0 0
Siena
Country [89] 0 0
Netherlands
State/province [89] 0 0
Maastricht
Country [90] 0 0
Poland
State/province [90] 0 0
Gdansk
Country [91] 0 0
Poland
State/province [91] 0 0
Poznan
Country [92] 0 0
Poland
State/province [92] 0 0
Przemysl
Country [93] 0 0
Poland
State/province [93] 0 0
Warsaw
Country [94] 0 0
Spain
State/province [94] 0 0
A Coruña
Country [95] 0 0
Spain
State/province [95] 0 0
Barcelona
Country [96] 0 0
Spain
State/province [96] 0 0
Girona
Country [97] 0 0
Spain
State/province [97] 0 0
Jerez De La Frontera
Country [98] 0 0
Spain
State/province [98] 0 0
Madrid
Country [99] 0 0
Spain
State/province [99] 0 0
Málaga
Country [100] 0 0
Spain
State/province [100] 0 0
Sevilla
Country [101] 0 0
Spain
State/province [101] 0 0
Valencia
Country [102] 0 0
Turkey
State/province [102] 0 0
Ankara
Country [103] 0 0
Turkey
State/province [103] 0 0
Edirne
Country [104] 0 0
Turkey
State/province [104] 0 0
Istanbul
Country [105] 0 0
Turkey
State/province [105] 0 0
Kadiköy
Country [106] 0 0
Turkey
State/province [106] 0 0
Konya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dizal Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Caicun Zhou
Address 0 0
Shanghai Pulmonary Hospital, Shanghai, China
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cyrus Cai, M.D.
Address 0 0
Country 0 0
Phone 0 0
+86 21 6109 5805
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05668988