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This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer
Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGA-, NSCLC without systemic therapy | Experimental | Combination Therapy |
|
| AGA-,PD-1+, NSCLC without systemic therapy | Experimental | Monotherapy |
|
| EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment | Experimental | Combination Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC148 plus Carboplatin and Paclitaxel/pemetrexed | Drug | RC148; Carboplatin; Paclitaxel; pemetrexed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier. | 24 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| li zhang | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital of Capital Medical University | Beijing | Beijing Municipality | China | |||
| Peking University Cancer Hospital |
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|
| RC148 | Drug | RC148 Monotherapy |
|
|
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier. |
| 24 months |
| Progression-free survival (PFS) | Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier. | 24 months |
| Overall survival (OS) | Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier. | 24 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 RC148 anti-drug antibody (ADA) | Serum samples will be collected from participants for ADA analysis of RC148. The blood sampling time points and time windows are described in protocol | 24 months |
| Maximum observed concentration (Cmax) of RC148 | Serum concentrations of RC148 in individual subjects at different time points after RC148 administration | 24 months |
| Beijing |
| Beijing Municipality |
| China |
| Shunde Hospital of Southern Medical University | Foshan | Guangdong | China |
| The First People's Hospital of Shunde | Foshan | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
| The First affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | China |
| The Second Affiliated Hospital of Guilin Medical College | Gulin | Guangxi | China |
| Affiliated Cancer Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China |
| Nanyang Second General Hospital | Hanyang | Henan | China |
| The First Affiliated Hospital of Xinxiang Medical College | Xinxiang | Henan | China |
| Henan cancer hospital | Zhengzhou | Henan | China |
| Union Hospital Tongji Medical College Huazhong University Of Science And Technologe | Wuhan | Hubei | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | China |
| Jinan Central Hospital | Jinan | Shandong | China |
| Linyi Cancer Hospital | Linyi | Shandong | China |
| Tianjin Medical University Cancer Institute Hospital | Tianjin | Tianjin Municipality | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 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 |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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