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

August 12, 2026 updated by: Allist Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Not yet recruiting
        • Anhui Province Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, China, 100005
        • Not yet recruiting
        • Pecking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100070
        • Not yet recruiting
        • Beijing Tiantan Hospital, Captal Medical University
      • Beijing, Beijing Municipality, China, 101125
        • Recruiting
        • Beijing Chest Hospital ,Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
      • Shenzhen, Guangdong, China, 518116
        • Not yet recruiting
        • Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Recruiting
        • Cangzhou hospital of integrated TCM-WM Hebei
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital-Mammary gland of internal
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hosipital Of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital Tongji Medical College of HUST
    • Hunan
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Province Hospital
      • Wuxi, Jiangsu, China, 214023
        • Not yet recruiting
        • Wuxi People's Hospital
    • Jilin
      • Jilin City, Jilin, China, 130021
        • Not yet recruiting
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • the First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110801
        • Not yet recruiting
        • Liaoning Cancer Hospital & Institute
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Cancer Hospital
      • Linyi, Shandong, China, 276002
        • Not yet recruiting
        • Linyi Cancer Hospital
      • Qingdao, Shandong, China, 266003
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200433
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Province Cancer Hospital
      • Xi’an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan province cancer hospital
      • Chengdu, Sichuan, China, 610044
        • Not yet recruiting
        • West China Hospital Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300181
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School Of Medicine
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang School of Medicine
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting
        • Taizhou Hospital Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JAB-21822+JAB-3312
JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle
Drug: JAB-21822
JAB-21822 administered orally as a tablet
Drug: JAB-3312
JAB-3312 administered orally as a tablet or capsule
Active Comparator: 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
Drug: Pemetrexed
Pemetrexed administered as an intravenous (IV) infusion
Drug: Carboplatin
Carboplatin administered as an intravenous (IV) infusion
Drug: Tislelizumab
Tislelizumab administered as an intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Progression-free Survival (PFS)
Time Frame: From Baseline up to 4 years
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC).
From Baseline up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From Baseline up to 4 years
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1
From Baseline up to 4 years
Overall Survival (OS)
Time Frame: From Baseline up to 4 years
OS is defined as the time from randomization until death due to any cause
From Baseline up to 4 years
Number of Participants With Treatment-Emergent Adverse Events
Time Frame: From Baseline up to 4 years
From Baseline up to 4 years
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: From Baseline up to 4 years
From Baseline up to 4 years
Time to Maximum Plasma Concentration (Tmax)
Time Frame: Pre-dose Day 1 up to Day 64
Pre-dose Day 1 up to Day 64
Half life (t1/2)
Time Frame: Pre-dose Day 1 up to Day 64
Pre-dose Day 1 up to Day 64

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Self-Evaluation Results (PRO)
Time Frame: From Baseline up to 4 years
To be assessed by EORTC OLO-LC13
From Baseline up to 4 years
Patient Self-Evaluation Results (PRO)
Time Frame: From Baseline up to 4 years
To be assessed by EORTC OLO-C30
From Baseline up to 4 years
Patient Self-Evaluation Results (PRO)
Time Frame: From Baseline up to 4 years
To be assessed by EuroQoL(EQ)5D
From Baseline up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allist Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Wang Jie M.D., Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAB-21822-3002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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