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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2027-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Advanced Non-squamous Non-small-cell Lung Cancer Metastatic Non-squamous Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

JAB-21822

Intervention Type DRUG

JAB-21822 administered orally as a tablet

JAB-3312

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Tislelizumab

Intervention Type DRUG

Tislelizumab administered as an intravenous (IV) infusion

Pemetrexed

Intervention Type DRUG

Pemetrexed administered as an intravenous (IV) infusion

Carboplatin

Intervention Type DRUG

Carboplatin administered as an intravenous (IV) infusion

Interventions

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JAB-21822

JAB-21822 administered orally as a tablet

Intervention Type DRUG

Tislelizumab

Tislelizumab administered as an intravenous (IV) infusion

Intervention Type DRUG

JAB-3312

JAB-3312 administered orally as a tablet or capsule

Intervention Type DRUG

Pemetrexed

Pemetrexed administered as an intravenous (IV) infusion

Intervention Type DRUG

Carboplatin

Carboplatin administered as an intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allist Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Pecking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Tiantan Hospital, Captal Medical University

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chest Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian cancer Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

The first Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

Guangxi Medical University Cancer hospital & Guangxi Cancer Institute

Nanning, Guangxi, China

Site Status NOT_YET_RECRUITING

Cangzhou hospital of integrated TCM-WM Hebei

Cangzhou, Hebei, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital-Mammary gland of internal

Haerbin, Heilongjiang, China

Site Status NOT_YET_RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hosipital Of Zhengzhou University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Tongji Hospital Tongji Medical College of Hust

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Hubei cancer hospital

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Jiangsu province hospital

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, China

Site Status NOT_YET_RECRUITING

Jilin cancer hospital

Jilin, Jilin, China

Site Status NOT_YET_RECRUITING

The First Hospital Of China Medical University

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status RECRUITING

LinYi Cancer Hospital

Linyi, Shandong, China

Site Status NOT_YET_RECRUITING

The affiliated hospital of Qingdao university

Qingdao, Shandong, China

Site Status NOT_YET_RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Shanxi province cancer hospital

Taiyuan, Shanxi, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, China

Site Status NOT_YET_RECRUITING

Sichuan province cancer hospital

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Tianjin Medical University Cancer Institute Hospital

Tianjin, Tianjin Municipality, China

Site Status NOT_YET_RECRUITING

The First affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital Zhejiang School of Medicine

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Taizhou Hospital Zhejiang Province

Taizhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Shanghai Allist Pharmaceuticals Co., Ltd

Role: CONTACT

021-80423288

Other Identifiers

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JAB-21822-3002

Identifier Type: -

Identifier Source: org_study_id

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