Clinical trial NCT06416410: 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
Official title: An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Non-squamous Non-small-cell Lung Cancer
Metastatic Non-squamous Non Small Cell Lung Cancer
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Outcome Progression-free Survival (PFS)
timeFrame: From Baseline up to 4 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From Baseline up to 4 years
measure: Overall Survival (OS)
timeFrame: From Baseline up to 4 years
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: From Baseline up to 4 years
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: From Baseline up to 4 years
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Pre-dose Day 1 up to Day 64
measure: Half life (t1/2)
timeFrame: Pre-dose Day 1 up to Day 64
Other outcomes:
measure: Patient Self-Evaluation Results (PRO)
timeFrame: From Baseline up to 4 years
measure: Patient Self-Evaluation Results (PRO)
timeFrame: From Baseline up to 4 years
measure: Patient Self-Evaluation Results (PRO)
timeFrame: From Baseline up to 4 years
Locations:
city: Hefei
country: China
facility: Anhui Province cancer hospital
state: Anhui
city: Beijing
country: China
facility: Pecking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy Of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Captal Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital ,Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Fujian cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: The first Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou hospital of integrated TCM-WM Hebei
state: Hebei
city: Haerbin
country: China
facility: Harbin Medical University Cancer Hospital-Mammary gland of internal
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hosipital Of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of Hust
state: Hubei
city: Wuhan
country: China
facility: Hubei cancer hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu province hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Jilin
country: China
facility: Jilin cancer hospital
state: Jilin
city: Shenyang
country: China
facility: The First Hospital Of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The affiliated hospital of Qingdao university
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi province cancer hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'An Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan province cancer hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First affiliated hospital Zhejiang university school of medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang School of Medicine
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Cancer Institute and Hospital
name: Wang Jie M.D.
role: PRINCIPAL_INVESTIGATOR
References: