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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03974022




Registration number
NCT03974022
Ethics application status
Date submitted
21/05/2019
Date registered
4/06/2019

Titles & IDs
Public title
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Scientific title
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation
Secondary ID [1] 0 0
DZ2019E0001
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

Experimental: Part A Dose escalation -

Experimental: Part A Dose expansion cohort 1 -

Experimental: Part A Dose expansion cohort 2 -

Experimental: Part A Dose expansion cohort 3 - Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy

Experimental: Part A Dose expansion cohort 4 - Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy

Experimental: Part A Dose expansion cohort 5 - Patients with EGFR Exon20ins, treatment naïve

Experimental: Part A Dose expansion cohort 6 -

Experimental: Part B Dose extension cohort 1 - Patients with EGFR Exon20ins

Experimental: Part B Dose extension cohort 2 - Patients with EGFR Exon20ins


Treatment: Drugs: Sunvozertinib
Daily dose of Sunvozertinib
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Safety and tolerability of Sunvozertinib.
Timepoint [1] 0 0
28 days after the first multiple dose
Primary outcome [2] 0 0
Part B: Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC).
Timepoint [2] 0 0
through the study completion, an average of around 1 year
Secondary outcome [1] 0 0
Part A: Plasma and urine Sunvozertinib concentrations, and derived PK parameters.
Timepoint [1] 0 0
Through cycle 3 day 1 (8 days for Cycle 0, 28 days for Cycle 1, then 21 days for each subsequent cycle)
Secondary outcome [2] 0 0
Part A: Plasma Sunvozertinib concentrations, and derived PK parameters
Timepoint [2] 0 0
Through the study completion
Secondary outcome [3] 0 0
Part A: ORR, BOR, DoR, DCR, %change in size of tumor lesion, PFS by investigator.
Timepoint [3] 0 0
Through the study completion
Secondary outcome [4] 0 0
Part A: ORR, DCR, DoR by IRC.
Timepoint [4] 0 0
Through the study completion
Secondary outcome [5] 0 0
Part B: DoR, PFS, DCR, BOR and % of change in size of tumor lesion according to RECIST 1.1 using assessments performed by an IRC; DoR, PFS, DCR, BOR and % of change in size of tumor lesion using investigators assessments accord.
Timepoint [5] 0 0
Through the study completion
Secondary outcome [6] 0 0
Part B: AEs/SAEs; Laboratory data; vital signs; physical examination; ECG; echocardiogram/MUGA; pulmonary function test.
Timepoint [6] 0 0
Through the study completion
Secondary outcome [7] 0 0
Part B: Plasma Sunvozertinib and metabolite concentration and derived PK parameters if deemed appropriately.
Timepoint [7] 0 0
Through the study completion

Eligibility
Key inclusion criteria
1. Aged at least 18 years old, be able to provide a signed and dated, written informed consent.
2. With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.
3. (ECOG) performance status 0-1.
4. Predicted life expectancy = 12 weeks
5. Patient must have measurable disease according to RECIST 1.1.
6. Patients with brain metastasis (BM) can be enrolled under the condition that BM is previously treated and stable, neurologically asymptomatic and does not require corticosteroid treatment.
7. Adequate organ system function.
8. Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve).

Part B Dose extension:
9. Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from a local CLIA-certified laboratory (or equivalent) or Sponsor designated central laboratory prior to the study entry.
10. Patients should have received at least 1 line, but no more than 3 lines of systemic therapy for metastatic/locally advanced disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. For part B: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment with currently approved EGFR TKIs for sensitizing or T790M resistance mutations, such as gefitinib, erlotinib, osimertinib, afatinib and dacomitinb, are allowed unless the patient had an objective response and subsequent progression assessed by the investigator.
2. Treatment with EGFR or HER2 antibodies, major surgery (excluding placement of vascular access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4) within 4 weeks before the first administration of Sunvozertinib.
3. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before the first administration.
4. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before the first administration.
5. Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A within 1-2 weeks before the first administration.
6. 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.
7. Spinal cord compression or leptomeningeal metastasis.
8. 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, human immunodeficiency virus (HIV) and COVID-19 (per local practice).
9. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs); (2) 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. (3) Any factors that increase the risk of QTF 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; (4) Prior history of atrial fibrillation within 6 months of first administration of Sunvozertinib, except prior drug treatment related and recovered.
10. 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.
11. 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.
12. History of hypersensitivity to active or inactive excipients of Sunvozertinib or drugs with a similar chemical structure or class to Sunvozertinib.
13. Women who are pregnant or breast feeding.
14. Involvement in the planning and conduct of the study.
15. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - East Melbourne - North Melbourne
Recruitment hospital [6] 0 0
Linear Cancer trials - Perth
Recruitment hospital [7] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- North Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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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
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Cabildo
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Autónoma Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Pergamino
Country [12] 0 0
Argentina
State/province [12] 0 0
Viedma
Country [13] 0 0
Canada
State/province [13] 0 0
Toronto
Country [14] 0 0
Chile
State/province [14] 0 0
Providencia
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Chile
State/province [16] 0 0
Temuco
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China
State/province [17] 0 0
Beijing
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China
State/province [18] 0 0
Changchun
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China
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Changsha
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China
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Chengdu
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China
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Chongqing
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China
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Fuzhou
Country [23] 0 0
China
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Guangzhou
Country [24] 0 0
China
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Haikou
Country [25] 0 0
China
State/province [25] 0 0
Hangzhou
Country [26] 0 0
China
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Harbin
Country [27] 0 0
China
State/province [27] 0 0
Hefei
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China
State/province [28] 0 0
Henan
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China
State/province [29] 0 0
Hohhot
Country [30] 0 0
China
State/province [30] 0 0
Huai'an
Country [31] 0 0
China
State/province [31] 0 0
Jinan
Country [32] 0 0
China
State/province [32] 0 0
Linyi
Country [33] 0 0
China
State/province [33] 0 0
Nanchang
Country [34] 0 0
China
State/province [34] 0 0
Nanning
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China
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Shanghai
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China
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Shenyang
Country [37] 0 0
China
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Taiyuan
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China
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Taizhou
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China
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Tianjin
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China
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Wuhan
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China
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Xi'an
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China
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Zhengzhou
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France
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Angers
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France
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Bron
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France
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Dijon
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France
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Hellemmes Lille
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France
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Marseille
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France
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Montpellier
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France
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Paris
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France
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Poitiers
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France
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Saint-Herblain
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France
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Saint-Mandé
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France
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Toulouse
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France
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Villejuif
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Italy
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Aviano
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Italy
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Catania
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Italy
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Firenze
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Italy
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Meldola
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Italy
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Milano
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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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Japan
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Matsuyama-shi
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Japan
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Nagoya-Shi
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Japan
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Niigata-Shi
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Japan
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Okayama-Shi
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Japan
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Tokushima-Shi
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Japan
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Tokyo
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Korea, Republic of
State/province [70] 0 0
Cheonju
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Goyang
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seongnam
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Seoul
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Suwon
Country [75] 0 0
Malaysia
State/province [75] 0 0
Johor Bahru
Country [76] 0 0
Malaysia
State/province [76] 0 0
Kuala Lumpur
Country [77] 0 0
Spain
State/province [77] 0 0
Barcelona
Country [78] 0 0
Spain
State/province [78] 0 0
Girona
Country [79] 0 0
Spain
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Jerez de la Frontera
Country [80] 0 0
Spain
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Madrid
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Spain
State/province [81] 0 0
Malaga
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Spain
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Sevilla
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Spain
State/province [83] 0 0
Valencia
Country [84] 0 0
Taiwan
State/province [84] 0 0
Liuying
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taichung
Country [86] 0 0
Taiwan
State/province [86] 0 0
Tainan
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taipei
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taoyuan

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
Pasi Antero Jänne, M.D & Ph. D
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT03974022