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

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: Advanced Non-squamous Non-small-cell Lung Cancer; Metastatic Non-squamous Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: JAB-21822; Drug: JAB-3312; Drug: Pemetrexed; Drug: Carboplatin; Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Estimated): 392
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shanghai Allist Pharmaceuticals Co., Ltd; Phone Number: 021-80423288; Email: zhenhua.gong@allist.com.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Not yet recruiting
      • Anhui Province Cancer Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 100005
      • Not yet recruiting
      • Pecking Union Medical College Hospital
    • Beijing, Beijing, China, 100070
      • Not yet recruiting
      • Beijing Tiantan Hospital, Captal Medical University
    • Beijing, Beijing, 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, 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
    • Shanghai, Shanghai, China, 200032
      • Not yet recruiting
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, 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
    • Tianjin, Tianjin, 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)	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)	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		From Baseline up to 4 years
Number of Participants With Clinically Significant Changes in Vital Signs		From Baseline up to 4 years
Time to Maximum Plasma Concentration (Tmax)		Pre-dose Day 1 up to Day 64
Half life (t1/2)		Pre-dose Day 1 up to Day 64

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allist Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Wang Jie M.D., Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027

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): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Pemetrexed; Tislelizumab; Carboplatin
• Other Study ID Numbers: JAB-21822-3002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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