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

Last updated: April 3, 2025
Sponsor: Allist Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Carboplatin

JAB-3312

Tirellizumab

Clinical Study ID

NCT06416410
JAB-21822-3002
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • A signed written informed consent is required before performing any study-relatedoperations

  • Age greater than or equal to 18 years old

  • Histologically or cytologically confirmed locally advanced/metastatic, unresectablenon-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

Exclusion Criteria:

  • Previous (≤2 years) or current solid tumors or hematologic tumors of otherpathological types

  • Carry other driver gene mutations with available target therapy, or carry other KRASmutations

  • 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

Study Design

Total Participants: 392
Treatment Group(s): 6
Primary Treatment: Carboplatin
Phase: 3
Study Start date:
August 07, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Anhui Province cancer hospital

    Hefei, Anhui 230031
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Beijing Chest Hospital ,Capital Medical University

    Beijing, Beijing 101125
    China

    Active - Recruiting

  • Beijing Tiantan Hospital, Captal Medical University

    Beijing, Beijing 100070
    China

    Site Not Available

  • Cancer Hospital Chinese Academy Of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Pecking Union Medical College Hospital

    Beijing, Beijing 100005
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Fujian cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • The first Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

    Shenzhen, Guangdong 518116
    China

    Site Not Available

  • Guangxi Medical University Cancer hospital & Guangxi Cancer Institute

    Nanning, Guangxi 530000
    China

    Site Not Available

  • Cangzhou hospital of integrated TCM-WM Hebei

    Cangzhou, Hebei 061000
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital-Mammary gland of internal

    Haerbin, Heilongjiang 150081
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The First Affiliated Hosipital Of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Hubei cancer hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College of Hust

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410031
    China

    Site Not Available

  • Jiangsu province hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Jilin cancer hospital

    Jilin, Jilin 130021
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning 110801
    China

    Site Not Available

  • The First Hospital Of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • LinYi Cancer Hospital

    Linyi, Shandong 276002
    China

    Site Not Available

  • The affiliated hospital of Qingdao university

    Qingdao, Shandong 266003
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Shanxi province cancer hospital

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • Sichuan province cancer hospital

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, Sichuan 610044
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute Hospital

    Tianjin, Tianjin 300181
    China

    Site Not Available

  • The First affiliated hospital Zhejiang university school of medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Taizhou Hospital Zhejiang Province

    Taizhou, Zhejiang 317000
    China

    Site Not Available

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