Trial Title:
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
Condition:
Advanced Non-squamous Non-small-cell Lung Cancer
Metastatic Non-squamous Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Tislelizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JAB-21822
Description:
JAB-21822 administered orally as a tablet
Arm group label:
JAB-21822+JAB-3312
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab administered as an intravenous (IV) infusion
Arm group label:
Tislelizumab combined with Pemetrexed + Carboplatin
Intervention type:
Drug
Intervention name:
JAB-3312
Description:
JAB-3312 administered orally as a tablet or capsule
Arm group label:
JAB-21822+JAB-3312
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed administered as an intravenous (IV) infusion
Arm group label:
Tislelizumab combined with Pemetrexed + Carboplatin
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin administered as an intravenous (IV) infusion
Arm group label:
Tislelizumab combined with Pemetrexed + Carboplatin
Summary:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- A signed written informed consent is required before performing any study-related
operations
- 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:
- Previous (≤2 years) or current solid tumors or hematologic tumors of other
pathological types
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Province cancer hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Pecking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Cancer Hospital Chinese Academy Of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Tiantan Hospital, Captal Medical University
Address:
City:
Beijing
Zip:
100070
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Chest Hospital ,Capital Medical University
Address:
City:
Beijing
Zip:
101125
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The first Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Address:
City:
Shenzhen
Zip:
518116
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Cangzhou hospital of integrated TCM-WM Hebei
Address:
City:
Cangzhou
Zip:
061000
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital-Mammary gland of internal
Address:
City:
Haerbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First Affiliated Hosipital Of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Tongji Hospital Tongji Medical College of Hust
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hubei cancer hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jiangsu province hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Wuxi People's Hospital
Address:
City:
Wuxi
Zip:
214023
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jilin cancer hospital
Address:
City:
Jilin
Zip:
130021
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Facility:
Name:
LinYi Cancer Hospital
Address:
City:
Linyi
Zip:
276002
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The affiliated hospital of Qingdao university
Address:
City:
Qingdao
Zip:
266003
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Shanxi province cancer hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First Affiliated Hospital of Xi'An Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Sichuan province cancer hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First affiliated hospital Zhejiang university school of medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Second Affiliated Hospital Zhejiang School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Taizhou Hospital Zhejiang Province
Address:
City:
Taizhou
Zip:
317000
Country:
China
Status:
Not yet recruiting
Start date:
August 7, 2024
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Jacobio Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Jacobio Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06416410
