A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Non-small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668988
• Other study ID #: DZ2022E0005
• Status: Recruiting
• Phase: Phase 3
• Start date: December 13, 2022
• Est. completion date: October 31, 2027

Study information

• Verified date: May 2024
• Source: Dizal Pharmaceuticals
• Contact: Cyrus Cai, M.D.
• Phone: +86 21 6109 5805
• Email: cyrus.cai[@]dizalpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: October 31, 2027
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• DZD9008
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
• 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.

Locations

Country	Name	City	State
Argentina	WK28 Investigative Site	Buenos Aires
Argentina	WK28 Investigative Site	Rosario
Argentina	WK28 Investigative Site	San Salvador De Jujuy
Australia	WK28 Investigative Site	Concord
Australia	WK28 Investigative Site	Melbourne
Australia	WK28 Investigative Site	Nedlands
Australia	WK28 Investigative Site	Randwick
Austria	WK28 Investigative Site	Linz
Austria	WK28 Investigative Site	Salzburg
Belgium	Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame	Charleroi	Hainaut
Belgium	Antwerpen University Hospital (UZA)	Edegem	Antwerp
Belgium	University Hospital Gent- Drug Research Unit Ghent (D.R.U.G.)	Ghent	Flanders
Brazil	WK28 Investigative Site	Barretos
Brazil	WK28 Investigative Site	Cachoeiro De Itapemirim
Brazil	WK28 Investigative Site	Natal
Brazil	WK28 Investigative Site	Porto Alegre
Brazil	WK28 Investigative Site	Recife
Brazil	WK28 Investigative Site	Rio De Janeiro
Brazil	WK28 Investigative Site	São Paulo
Canada	WK28 Investigative Site	London	Ontario
Canada	WK28 Investigative Site	Ottawa
Canada	WK28 Investigative Site	Toronto
China	Beijing Cancer Hospital	Beijing
China	Beijing Chest Hospital, Capital Medical University	Beijing
China	Cancer Hospital of the Chinese Academy of Medical Sciences	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Hunan Cancer Hospital	Changsha
China	West China Hospital of Sichuan University	Chengdu
China	Army Medical Center of PLA	Chongqing
China	Chongqing Cancer Hospital	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	Fujian Medical University Union Hospital	Fuzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou
China	Harbin Medical University Cancer Hospital	Ha'erbin
China	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Anhui Provincial Hospital	Hefei
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot
China	Jilin Cancer Hospital	Jilin
China	Central Hospital Affiliated to Shandong First Medical University	Jinan
China	Shandong Cancer Hospital & Institution	Jinan
China	Yunnan Cancer Hospital	Kunming
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	Jiangsu Cancer Hospital	Nanjing
China	Jiangsu Provincial Hospital	Nanjing
China	Guangxi Medical University Cancer Hospital	Nanning
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	ZhongShan Hospital Fudan University	Shanghai
China	The First Hospital of China Medical University	Shenyang
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang
China	Shanxi Provincial Cancer Hospital	Taiyuan
China	Taizhou Hospital of Zhejiang Province	Taizhou
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an
China	Yantai Yuhuangding Hospital	Yantai
China	Henan Cancer Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Czechia	WK28 Investigative Site	Olomouc
Czechia	WK28 Investigative Site	Ostrava
France	WK28 Investigative Site	Angers
France	WK28 Investigative Site	Bron
France	WK28 Investigative Site	Créteil
France	WK28 Investigative Site	La Tronche
France	WK28 Investigative Site	Lille
France	WK28 Investigative Site	Marseille
France	WK28 Investigative Site	Montpellier
France	WK28 Investigative Site	Nantes
France	WK28 Investigative Site	Paris
France	WK28 Investigative Site	Paris
France	WK28 Investigative Site	Poitiers
France	WK28 Investigative Site	Saint Herblain
France	WK28 Investigative Site	Saint-Mandé
France	WK28 Investigative Site	Suresnes
Germany	WK28 Investigative Site	Berlin
Germany	WK28 Investigative Site	Gauting
Germany	WK28 Investigative Site	Georgsmarienhütte
Germany	WK28 Investigative Site	Heidelberg
Germany	WK28 Investigative Site	Mainz
Italy	WK28 Investigative Site	Aviano
Italy	WK28 Investigative Site	Bologna
Italy	WK28 Investigative Site	Catania
Italy	WK28 Investigative Site	Florence
Italy	WK28 Investigative Site	Grosseto
Italy	WK28 Investigative Site	Meldola
Italy	WK28 Investigative Site	Modena
Italy	WK28 Investigative Site	Monza
Italy	WK28 Investigative Site	Palermo
Italy	WK28 Investigative Site	Parma
Italy	WK28 Investigative Site	Ravenna
Italy	WK28 Investigative Site	Reggio Emilia
Italy	WK28 Investigative Site	Roma
Italy	WK28 Investigative Site	Siena
Netherlands	WK28 Investigative Site	Maastricht
Poland	WK28 Investigative Site	Gdansk
Poland	WK28 Investigative Site	Poznan
Poland	WK28 Investigative Site	Przemysl
Spain	WK28 Investigative Site	A Coruña
Spain	WK28 Investigative Site	Barcelona
Spain	WK28 Investigative Site	Barcelona
Spain	WK28 Investigative Site	Girona
Spain	WK28 Investigative Site	Jerez De La Frontera
Spain	WK28 Investigative Site	Madrid
Spain	WK28 Investigative Site	Málaga
Spain	WK28 Investigative Site	Sevilla
Spain	WK28 Investigative Site	Valencia
Turkey	WK28 Investigative Site	Ankara
Turkey	WK28 Investigative Site	Cubuk
Turkey	WK28 Investigative Site	Edirne
Turkey	WK28 Investigative Site	Istanbul
Turkey	WK28 Investigative Site	Kadiköy
Turkey	WK28 Investigative Site	Konya
United States	WK28 Investigative Site	Aurora	Colorado
United States	WK28 Investigative Site	Canton	Ohio
United States	WK28 Investigative Site	Charlottesville	Virginia
United States	WK28 Investigative Site	Columbus	Ohio
United States	WK28 Investigative Site	Dallas	Texas
United States	WK28 Investigative Site	Glendale	California
United States	MD Anderson cancer center	Houston	Texas
United States	WK28 Investigative Site	Margate	Florida
United States	WK28 Investigative Site	New York	New York
United States	WK28 Investigative Site	New York	New York
United States	WK28 Investigative Site	New York	New York
United States	WK28 Investigative Site	Plantation	Florida
United States	WK28 Investigative Site	Portland	Oregon
United States	WK28 Investigative Site	Tampa	Florida
United States	WK28 Investigative Site	Vallejo	California
United States	WK28 Investigative Site	Weslaco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dizal Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1		Up to approximately 34 months after the first participant is randomized
Secondary	Overall Survival		Up to approximately 34 months after the first participant is randomized