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This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DZD6008 + Sunvozertinib | Experimental |
| |
| Osimertinib | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD6008 | Drug | DZD6008 will be administered orally at 40/60 mg QD or selected dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: To assess safety and tolerability | Number of participants with Adverse events (AEs)/Serious adverse events (SAEs) | Through the study completion, an average of around 2 years |
| Part A: To assess safety and tolerability | Number of participants with Dose-limiting Toxicities (DLTs) | 21 days after the first dose |
| Part B: To assess anti-tumor activity | Objective Response Rate (ORR) assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Through the study completion, an average of around 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: To assess the anti-tumor activity | ORR assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part A: To assess the anti-tumor activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YIFAN LIU | Contact | (86) 021-61095854 | yifan.liu@dizalpharma.com | |
| clinicaltrials@dizalpharma.com | Contact | clinicaltrials@dizalpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital | Recruiting | Beijing | Beijing Municipality | 101125 | China |
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| Sunvozertinib | Drug | Sunvozertinib will be administered orally at 100/200 mg QD or selected dose. |
|
| Osimertinib | Drug | Osimertinib will be administered orally at 80 mg QD |
|
Duration of Response (DoR) assessed by investigator per RECIST version 1.1
| Through the study completion, an average of around 2 years |
| Part A: To assess the anti-tumor activity | Disease Control Rate (DCR) assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part A: To assess the anti-tumor activity | Percentage change in tumor size assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part A: To assess the anti-tumor activity | Progression Free Survival (PFS) assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part A: To characterize the Pharmacokinetics of DZD6008 | To characterize the concentration of DZD6008 in plasma and cerebrospinal fluid (selected participants with brain metastasis). | Through the study until the time specified in the protocol, an average of around half year. |
| Part A: To characterize the Pharmacokinetics of sunvozertinib and DZ0753 | To characterize the concentrations of sunvozertinib and DZ0753 in plasma and cerebrospinal fluid (selected participants with brain metastasis). | Through the study until the time specified in the protocol, an average of around half year. |
| Part B: To assess the anti-tumor activity | DoR assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part B: To assess the anti-tumor activity | DCR assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part B: To assess the anti-tumor activity | Percentage change in tumor size assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part B: To assess the anti-tumor activity | PFS assessed by investigator per RECIST version 1.1 | Through the study completion, an average of around 2 years |
| Part B: To assess safety and tolerability | Number of participants with AEs /SAEs | Through the study completion, an average of around 2 years |
| Part B: To characterize the Pharmacokinetics of DZD6008 | To characterize the concentration of DZD6008 in plasma and cerebrospinal fluid (selected participants with brain metastasis). | Through the study until the time specified in the protocol, an average of around half year. |
| Part B: To characterize the Pharmacokinetics of sunvozertinib and DZ0753 | To characterize the concentration of sunvozertinib and DZ0753 in plasma and cerebrospinal fluid (selected participants with brain metastasis). | Through the study until the time specified in the protocol, an average of around half year. |
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| Harbin Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
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| Jiangsu People's Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| Nanjing Gulou Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | China |
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| First Affilicated Hospital of China Medical University | Not yet recruiting | Shengyang | Liaoning | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| The First Affilicated Hospital of Xi'An Jiaotong University | Not yet recruiting | Xi’an | Shanxi | China |
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| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 6100042 | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
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| Hangzhou Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Taizhou Hospital | Recruiting | Taizhou | Zhejiang | 317000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
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