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This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAB-21822+JAB-3312 | Experimental | JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle |
|
| Tislelizumab combined with Pemetrexed + Carboplatin | Active Comparator | Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-21822 | Drug | JAB-21822 administered orally as a tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Progression-free Survival (PFS) | PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC). | From Baseline up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1 | From Baseline up to 4 years |
| Overall Survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Self-Evaluation Results (PRO) | To be assessed by EORTC OLO-LC13 | From Baseline up to 4 years |
| Patient Self-Evaluation Results (PRO) | To be assessed by EORTC OLO-C30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanghai Allist Pharmaceuticals Co., Ltd | Contact | 021-80423288 | zhenhua.gong@allist.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wang Jie M.D. | Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province cancer hospital | Not yet recruiting | Hefei | Anhui | 230031 | China | |
| Pecking Union Medical College Hospital |
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| Tislelizumab |
| Drug |
Tislelizumab administered as an intravenous (IV) infusion |
|
| JAB-3312 | Drug | JAB-3312 administered orally as a tablet or capsule |
|
| Pemetrexed | Drug | Pemetrexed administered as an intravenous (IV) infusion |
|
| Carboplatin | Drug | Carboplatin administered as an intravenous (IV) infusion |
|
OS is defined as the time from randomization until death due to any cause
| From Baseline up to 4 years |
| Number of Participants With Treatment-Emergent Adverse Events | From Baseline up to 4 years |
| Number of Participants With Clinically Significant Changes in Vital Signs | From Baseline up to 4 years |
| Time to Maximum Plasma Concentration (Tmax) | Pre-dose Day 1 up to Day 64 |
| Half life (t1/2) | Pre-dose Day 1 up to Day 64 |
| From Baseline up to 4 years |
| Patient Self-Evaluation Results (PRO) | To be assessed by EuroQoL(EQ)5D | From Baseline up to 4 years |
| Not yet recruiting |
| Beijing |
| Beijing Municipality |
| 100005 |
| China |
| Cancer Hospital Chinese Academy Of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| Beijing Tiantan Hospital, Captal Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100070 | China |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| Beijing Chest Hospital ,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101125 | China |
| Fujian cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
| The first Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
| Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center | Not yet recruiting | Shenzhen | Guangdong | 518116 | China |
| Guangxi Medical University Cancer hospital & Guangxi Cancer Institute | Not yet recruiting | Nanning | Guangxi | 530000 | China |
| Cangzhou hospital of integrated TCM-WM Hebei | Recruiting | Cangzhou | Hebei | 061000 | China |
| Harbin Medical University Cancer Hospital-Mammary gland of internal | Not yet recruiting | Haerbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hosipital Of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
| Tongji Hospital Tongji Medical College of Hust | Not yet recruiting | Wuhan | Hubei | 430030 | China |
| Hubei cancer hospital | Not yet recruiting | Wuhan | Hubei | 430079 | China |
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
| Jiangsu province hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
| Wuxi People's Hospital | Not yet recruiting | Wuxi | Jiangsu | 214023 | China |
| Jilin cancer hospital | Not yet recruiting | Jilin City | Jilin | 130021 | China |
| The First Hospital Of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
| Liaoning Cancer Hospital & Institute | Not yet recruiting | Shenyang | Liaoning | 110801 | China |
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250012 | China |
| LinYi Cancer Hospital | Not yet recruiting | Linyi | Shandong | 276002 | China |
| The affiliated hospital of Qingdao university | Not yet recruiting | Qingdao | Shandong | 266003 | China |
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| Shanxi province cancer hospital | Not yet recruiting | Taiyuan | Shanxi | 030013 | China |
| The First Affiliated Hospital of Xi'An Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
| Sichuan province cancer hospital | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
| West China Hospital Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610044 | China |
| Tianjin Medical University Cancer Institute Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300181 | China |
| The First affiliated hospital Zhejiang university school of medicine | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
| The Second Affiliated Hospital Zhejiang School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
| Taizhou Hospital Zhejiang Province | Not yet recruiting | Taizhou | Zhejiang | 317000 | China |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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