A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Launched by DIZAL PHARMACEUTICALS · Dec 20, 2022
Trial Information
Current as of September 06, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called WU-KONG28, is studying a new treatment called DZD9008 compared to standard chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation known as EGFR Exon20ins. The trial is for adults who are newly diagnosed or have not received prior treatments for their advanced cancer. Researchers want to find out if DZD9008 is more effective than the standard platinum-based chemotherapy in helping patients live longer without their cancer worsening.
To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of non-squamous NSCLC that is either locally advanced or metastatic (meaning it has spread to other parts of the body). They also need to have adequate tumor tissue for testing the genetic mutation and at least one measurable tumor. Participants who join the trial will be randomly assigned to receive either DZD9008 or the standard chemotherapy. The trial is currently recruiting and aims to include around 320 participants. It's important to note that patients with certain conditions, like prior treatments for cancer or specific brain issues, may not be eligible to join.
Gender
ALL
Eligibility criteria
- 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).
About Dizal Pharmaceuticals
Dizal Pharmaceuticals is a biopharmaceutical company dedicated to the discovery and development of innovative therapies for unmet medical needs. With a focus on advancing treatments in areas such as oncology and rare diseases, Dizal leverages cutting-edge technology and a robust scientific approach to create novel drug candidates. Committed to improving patient outcomes, the company emphasizes collaboration with healthcare professionals and research institutions to bring transformative solutions from the lab to clinical practice. Through rigorous clinical trials and a patient-centered ethos, Dizal Pharmaceuticals aims to make a meaningful impact on the lives of individuals facing challenging health conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Madrid, , Spain
Valencia, , Spain
Portland, Oregon, United States
Houston, Texas, United States
Columbus, Ohio, United States
Tampa, Florida, United States
Vallejo, California, United States
Madrid, , Spain
Barcelona, , Spain
Beijing, , China
Poitiers, , France
Barcelona, , Spain
Paris, , France
Shanghai, , China
Buenos Aires, , Argentina
Melbourne, Victoria, Australia
Chengdu, , China
Nanjing, , China
Angers, , France
Beijing, , China
Shanghai, , China
Canton, Ohio, United States
Beijing, , China
Suresnes, , France
Sevilla, , Spain
Shenyang, , China
Parma, , Italy
Hefei, , China
Málaga, , Spain
Yantai, , China
Sevilla, , Spain
Shanghai, Shanghai, China
Paris, , France
Valencia, , Spain
Wuhan, , China
Fuzhou, , China
Hangzhou, , China
Shanghai, , China
Changsha, , China
Zhengzhou, Henan, China
Randwick, , Australia
Chongqing, , China
Sevilla, , Spain
Fuzhou, , China
Guangzhou, , China
Zhengzhou, , China
Hefei, , China
Zhengzhou, , China
Nanjing, , China
Beijing, , China
Aurora, Colorado, United States
Istanbul, , Turkey
Toronto, , Canada
A Coruña, , Spain
Bron, , France
Salzburg, , Austria
Harbin, , China
Kunming, , China
Linz, , Austria
Tianjin, , China
Nanchang, , China
Jerez De La Frontera, , Spain
Guangzhou, , China
Ha'erbin, , China
Shijiazhuang, , China
Nanning, , China
Konya, , Turkey
Porto Alegre, , Brazil
Nanchang, Jiangxi, China
Taizhou, , China
Taiyuan, , China
Jilin, , China
Hohhot, , China
Edirne, , Turkey
Saint Herblain, , France
Chongqing, , China
Dallas, Texas, United States
Charlottesville, Virginia, United States
Madrid, , Spain
Poznań, , Poland
Beijing, , China
Hangzhou, , China
Jinan, , China
Jinan, , China
Wuhan, , China
Xi'an, , China
Guangzhou, Guangdong, China
Shenzhen, , China
Glendale, California, United States
Gdańsk, , Poland
Rio De Janeiro, , Brazil
Glendale, California, United States
Vallejo, California, United States
Aurora, Colorado, United States
Margate, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
New York, New York, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Dallas, Texas, United States
Weslaco, Texas, United States
Charlottesville, Virginia, United States
Buenos Aires, , Argentina
Rosario, , Argentina
San Salvador De Jujuy, , Argentina
Concord, , Australia
Melbourne, , Australia
Nedlands, , Australia
Randwick, , Australia
Linz, , Austria
Salzburg, , Austria
Edegem, Antwerp, Belgium
Ghent, Flanders, Belgium
Charleroi, Hainaut, Belgium
Barretos, , Brazil
Cachoeiro De Itapemirim, , Brazil
Natal, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
London, Ontario, Canada
Ottawa, , Canada
Toronto, , Canada
Olomouc, , Czechia
Ostrava, , Czechia
Angers, , France
Bron, , France
Créteil, , France
La Tronche, , France
Lille, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Paris, , France
Poitiers, , France
Saint Herblain, , France
Saint Mandé, , France
Suresnes, , France
Berlin, , Germany
Gauting, , Germany
Georgsmarienhütte, , Germany
Heidelberg, , Germany
Mainz, , Germany
Aviano, , Italy
Bologna, , Italy
Catania, , Italy
Florence, , Italy
Grosseto, , Italy
Meldola, , Italy
Modena, , Italy
Monza, , Italy
Palermo, , Italy
Parma, , Italy
Ravenna, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Siena, , Italy
Maastricht, , Netherlands
Gdańsk, , Poland
Poznań, , Poland
Przemyśl, , Poland
A Coruña, , Spain
Barcelona, , Spain
Girona, , Spain
Jerez De La Frontera, , Spain
Madrid, , Spain
Málaga, , Spain
Sevilla, , Spain
Valencia, , Spain
Ankara, , Turkey
Cubuk, , Turkey
Edirne, , Turkey
Istanbul, , Turkey
Kadıköy, , Turkey
Konya, , Turkey
Madrid, , Spain
Paris, , France
Plantation, Florida, United States
Marseille, , France
Margate, Florida, United States
New York, New York, United States
Weslaco, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
San Salvador, , Argentina
Viedma, , Argentina
Concord, , Australia
Nedlands, , Australia
Barretos, , Brazil
Cachoeiro De Itapemirim, , Brazil
Natal, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Rio De Janeiro, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
London, , Canada
Ottawa, , Canada
Olomouc, , Czechia
Ostrava, , Czechia
Créteil, , France
Hellemmes Lille, , France
La Tronche, , France
Montpellier, , France
Paris, , France
Saint Herblain, , France
Saint Mande, , France
Berlin, , Germany
Gauting, , Germany
Georgsmarienhütte, , Germany
Heidelberg, , Germany
Mainz, , Germany
Oldenburg, , Germany
Aviano, , Italy
Bologna, , Italy
Catania, , Italy
Florence, , Italy
Grosseto, , Italy
Meldola, , Italy
Modena, , Italy
Monza, , Italy
Palermo, , Italy
Ravenna, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Siena, , Italy
Maastricht, , Netherlands
Przemyśl, , Poland
Warsaw, , Poland
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Kadıköy, , Turkey
Patients applied
Trial Officials
Caicun Zhou
Principal Investigator
Shanghai Pulmonary Hospital, Shanghai, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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