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

NCT06416410 | Recruiting Phase 3

• 1 other identifier: JAB-21822-3002
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 37

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Objective Response Rate (ORR)

  From Baseline up to 4 years

• Overall Survival (OS)

  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

Other Outcomes (3)

• Patient Self-Evaluation Results (PRO)

  From Baseline up to 4 years

• Patient Self-Evaluation Results (PRO)

  From Baseline up to 4 years

• Patient Self-Evaluation Results (PRO)

  From Baseline up to 4 years

Study Arms (2)

JAB-21822+JAB-3312

EXPERIMENTAL

JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle

Drug: JAB-21822; Drug: JAB-3312

Tislelizumab combined with Pemetrexed + Carboplatin

ACTIVE COMPARATOR

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: Tislelizumab; Drug: Pemetrexed; Drug: Carboplatin

Interventions

JAB-21822 DRUG

JAB-21822 administered orally as a tablet

JAB-21822+JAB-3312

Tislelizumab DRUG

Tislelizumab administered as an intravenous (IV) infusion

Tislelizumab combined with Pemetrexed + Carboplatin

JAB-3312 DRUG

JAB-3312 administered orally as a tablet or capsule

JAB-21822+JAB-3312

Pemetrexed DRUG

Pemetrexed administered as an intravenous (IV) infusion

Tislelizumab combined with Pemetrexed + Carboplatin

Carboplatin DRUG

Carboplatin administered as an intravenous (IV) infusion

Tislelizumab combined with Pemetrexed + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (37)

Anhui Province cancer hospital

Hefei, Anhui, 230031, China

NOT YET RECRUITING

Pecking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

NOT YET RECRUITING

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Tiantan Hospital, Captal Medical University

Beijing, Beijing Municipality, 100070, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Beijing Chest Hospital ,Capital Medical University

Beijing, Beijing Municipality, 101125, China

RECRUITING

Fujian cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

The first Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

Shenzhen, Guangdong, 518116, China

NOT YET RECRUITING

Guangxi Medical University Cancer hospital & Guangxi Cancer Institute

Nanning, Guangxi, 530000, China

NOT YET RECRUITING

Cangzhou hospital of integrated TCM-WM Hebei

Cangzhou, Hebei, 061000, China

RECRUITING

Harbin Medical University Cancer Hospital-Mammary gland of internal

Haerbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

The First Affiliated Hosipital Of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Tongji Hospital Tongji Medical College of Hust

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Hubei cancer hospital

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Jiangsu province hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

NOT YET RECRUITING

Jilin cancer hospital

Jilin, Jilin, 130021, China

NOT YET RECRUITING

The First Hospital Of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250012, China

RECRUITING

LinYi Cancer Hospital

Linyi, Shandong, 276002, China

NOT YET RECRUITING

The affiliated hospital of Qingdao university

Qingdao, Shandong, 266003, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Shanxi province cancer hospital

Taiyuan, Shanxi, 030013, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Sichuan province cancer hospital

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610044, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute Hospital

Tianjin, Tianjin Municipality, 300181, China

NOT YET RECRUITING

The First affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang School of Medicine

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

Taizhou Hospital Zhejiang Province

Taizhou, Zhejiang, 317000, China

NOT YET RECRUITING

MeSH Terms

Interventions

tislelizumab; Pemetrexed; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Wang Jie M.D.

  Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanghai Allist Pharmaceuticals Co., Ltd

CONTACT

021-80423288; zhenhua.gong@allist.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (37)