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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05668988




Registration number
NCT05668988
Ethics application status
Date submitted
20/12/2022
Date registered
30/12/2022
Date last updated
23/05/2024

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 - DZD9008
Treatment: Drugs - Pemetrexed+carboplatin

Experimental: DZD9008 -

Active Comparator: Platinum-based Chemotherapy -


Treatment: Drugs: DZD9008
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
WK28 Investigative Site - Concord
Recruitment hospital [2] 0 0
WK28 Investigative Site - Melbourne
Recruitment hospital [3] 0 0
WK28 Investigative Site - Nedlands
Recruitment hospital [4] 0 0
WK28 Investigative Site - 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
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Colorado
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Florida
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New York
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Ohio
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Oregon
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Argentina
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San Salvador De Jujuy
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Austria
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Linz
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Austria
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Salzburg
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Belgium
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Antwerp
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Belgium
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Flanders
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Belgium
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Hainaut
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Brazil
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Barretos
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Brazil
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Cachoeiro De Itapemirim
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Brazil
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Natal
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Brazil
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Porto Alegre
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Recife
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Rio De Janeiro
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São Paulo
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Canada
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Ontario
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Ottawa
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Canada
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Toronto
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China
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Beijing
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China
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Changsha
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Chengdu
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Chongqing
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Fuzhou
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Guangzhou
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Ha'erbin
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Hangzhou
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China
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Hefei
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Hohhot
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China
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Jilin
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Jinan
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Kunming
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Nanchang
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Nanjing
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Nanning
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Shanghai
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China
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Shenyang
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China
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Shijiazhuang
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Taiyuan
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China
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Taizhou
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Tianjin
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Wuhan
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Xi'an
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Yantai
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Zhengzhou
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Czechia
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Olomouc
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Czechia
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Ostrava
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Angers
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Bron
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Lille
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Nantes
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Paris
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Poitiers
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Saint Herblain
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Saint-Mandé
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Suresnes
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Germany
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Berlin
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Germany
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Gauting
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Germany
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Georgsmarienhütte
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Germany
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Heidelberg
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Germany
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Mainz
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Aviano
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Italy
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Bologna
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Italy
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Catania
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Italy
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Florence
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Italy
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Grosseto
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Italy
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Meldola
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Italy
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Modena
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Italy
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Monza
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Italy
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Palermo
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Italy
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Parma
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Italy
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Ravenna
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Siena
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Netherlands
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Maastricht
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Poland
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Gdansk
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Poland
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Poznan
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Przemysl
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Jerez De La Frontera
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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Valencia
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Turkey
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Ankara
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Cubuk
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Edirne
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Turkey
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Istanbul
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Turkey
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Kadiköy
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Turkey
State/province [104] 0 0
Konya

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and
safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally
advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have
not received prior systemic therapy in advanced stage.

Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based
doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint.
Approximately 320 participants are estimated to be randomized into the study. Participants
enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1
manner, stratified by baseline brain metastasis (with/without).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05668988
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
cyrus.cai@dizalpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05668988