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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
392

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allist Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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