JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation
NCT ID: NCT06416410
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
392 participants
INTERVENTIONAL
2024-08-07
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JAB-21822+JAB-3312
JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle
JAB-21822
JAB-21822 administered orally as a tablet
JAB-3312
JAB-3312 administered orally as a tablet or capsule
Tislelizumab combined with Pemetrexed + Carboplatin
Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle
Tislelizumab
Tislelizumab administered as an intravenous (IV) infusion
Pemetrexed
Pemetrexed administered as an intravenous (IV) infusion
Carboplatin
Carboplatin administered as an intravenous (IV) infusion
Interventions
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JAB-21822
JAB-21822 administered orally as a tablet
Tislelizumab
Tislelizumab administered as an intravenous (IV) infusion
JAB-3312
JAB-3312 administered orally as a tablet or capsule
Pemetrexed
Pemetrexed administered as an intravenous (IV) infusion
Carboplatin
Carboplatin administered as an intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years old
* Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
* No history of systemic anticancer therapy to the local advanced/metastatic disease
* Expected survival period greater than or equal to 3 months
* Having at least one target lesion according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
Exclusion Criteria
* Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
* Subjects with untreated central nervous system (CNS) metastases were excluded;
* Uncontrolled pleural effusion, pericardial effusion, and ascites
* Subjects with impaired heart function or clinically significant heart disease
18 Years
ALL
No
Sponsors
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Allist Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wang Jie M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital
Locations
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Anhui Province cancer hospital
Hefei, Anhui, China
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Fujian cancer Hospital
Fuzhou, Fujian, China
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, China
Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
Cangzhou hospital of integrated TCM-WM Hebei
Cangzhou, Hebei, China
Harbin Medical University Cancer Hospital-Mammary gland of internal
Haerbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hosipital Of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Hubei cancer hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu province hospital
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Jilin cancer hospital
Jilin, Jilin, China
The First Hospital Of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
LinYi Cancer Hospital
Linyi, Shandong, China
The affiliated hospital of Qingdao university
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi province cancer hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, China
Sichuan province cancer hospital
Chengdu, Sichuan, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute Hospital
Tianjin, Tianjin Municipality, China
The First affiliated hospital Zhejiang university school of medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang School of Medicine
Hangzhou, Zhejiang, China
Taizhou Hospital Zhejiang Province
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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JAB-21822-3002
Identifier Type: -
Identifier Source: org_study_id
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