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Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC
Primary objective: Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC Secondary objective: Evaluate the pharmacokinetic and immunogenicity characteristics of RC108 in combination with Furmonertinib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC |
|
| Arm 2 | Active Comparator | 1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC108 | Drug | RC108 in Combination With Furmonertinib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Investigator-assessed ORR | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Investigator-assessed PFS | 24 months |
| Disease Control Rate (DCR) | Investigator-assessed DCR | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heping Liu | Contact | +86-010-65384976 | heping.liu@remegen.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang | Hunan Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital,Capital Medical Unniversity | Recruiting | Beijing | China | |||
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| Furmonertinib Mesilate Tablets Monotherapy | Drug | Furmonertinib |
|
|
| Duration of Response (DoR) | Investigator-assessed DoR | 24 months |
| Overall survival (OS) | Investigator-assessed OS | 45 months |
| Number of participants with adverse events (AEs) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | 24 months |
| Incidence of RC108 anti-drug antibody (ADA) | Incidence, occurrence time and ADA titer of positive RC108 ADA and neutralizing antibodies | 24 months |
| Pharmacokinetic profile of RC108 | Peak and trough concentrations of RC108 total antibody (TAb), conjugated antibody (ADC), free MMAE | 24 months |
| The Fifth Medical Center of Chinese People's Liberation Army General Hospital |
| Recruiting |
| Beijing |
| China |
| Binzhou Medical University Hospital | Recruiting | Binzhou | China |
|
| Jilin Cancer Hospital | Recruiting | Changchun | China |
| The Second Xiangya Hospital Of Central South University | Recruiting | Changsha | China |
|
| Changzhou Cancer Hospital | Recruiting | Changzhou | China |
|
| Sichuan Cancer Hospital | Recruiting | Chengdu | China |
|
| West China hospitial of SiChuan University | Recruiting | Chengdu | China |
|
| Chongqing University Cancer Hospitai | Recruiting | Chongqing | China |
| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
|
| Ganzhou cancer Hospitial | Recruiting | Ganzhou | China |
|
| Affiliated Cancer Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Guilin | China |
|
| The Second Affiliated Hospital of Guilin Medical University | Recruiting | Guilin | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | China |
|
| Anhui Provincial cancer hospital | Recruiting | Hefei | China |
|
| The First hospitial of Anhui Medicine University | Recruiting | Hefei | China |
|
| Jinan Central Hospital | Recruiting | Jinan | China |
|
| Shandong Cancer Hospital | Recruiting | Jinan | China |
|
| The First hospitial of Lanzhou University | Recruiting | Lanzhou | China |
|
| Linyi People's Hospital | Recruiting | Linyi | China |
|
| THE FIRST HOSPITAI OF CHINA MEDICAL UNIVERSITY,No. 155, Nanjing North Street, Heping District, Shenyang City, Liaoning Province | Recruiting | Shenyang | China |
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
| Shanxi Cancer Hospital | Recruiting | Taiyuan | China |
| Taizhou hospitial of Zhejiang province | Recruiting | Taizhou | China |
|
| Tianjin Chest Hospital | Recruiting | Tianjin | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | China |
|
| Xiangyang Central Hospital | Recruiting | Xiangyang | China |
|
| The Second People's Hospital of Yibin City | Recruiting | Yibin | China |
|
| Yiyang Central Hospital | Recruiting | Yiyang | China |
|
| Yueyang Central Hospital | Recruiting | Yueyang | China |
|
| Yunnan Cancer Hospital | Recruiting | Yunnan | China |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
| 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 |
|---|---|
| D007267 | Injections |
| C000705711 | aflutinib |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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