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 · tracked via the Priya Life Science China tracker

Sponsor

Allist Pharmaceuticals, Inc.

Phase

Phase 3

Started

2024-08-07

Last updated

2026-08-13

Condition(s) studied

Advanced Non-squamous Non-small-cell Lung CancerMetastatic Non-squamous Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

JAB-21822 →Tislelizumab →JAB-3312Pemetrexed →Carboplatin →

JAB-21822: JAB-21822 administered orally as a tablet

Tislelizumab: Tislelizumab administered as an intravenous (IV) infusion

JAB-3312: JAB-3312 administered orally as a tablet or capsule

Pemetrexed: Pemetrexed administered as an intravenous (IV) infusion

Carboplatin: Carboplatin administered as an intravenous (IV) infusion

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Outcome Progression-free Survival (PFS) — 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).

Trial sites (37)

Facility	City	Region	Status
Anhui Province cancer hospital	Hefei	Anhui	Not Yet Recruiting
Pecking Union Medical College Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
Cancer Hospital Chinese Academy Of Medical Sciences	Beijing	Beijing Municipality	Recruiting
Beijing Tiantan Hospital, Captal Medical University	Beijing	Beijing Municipality	Not Yet Recruiting
Beijing Cancer Hospital	Beijing	Beijing Municipality	Recruiting
Peking University Third Hospital	Beijing	Beijing Municipality	Recruiting
Beijing Chest Hospital ,Capital Medical University	Beijing	Beijing Municipality	Recruiting
Fujian cancer Hospital	Fuzhou	Fujian	Not Yet Recruiting
The first Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Not Yet Recruiting
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center	Shenzhen	Guangdong	Not Yet Recruiting
Guangxi Medical University Cancer hospital & Guangxi Cancer Institute	Nanning	Guangxi	Not Yet Recruiting
Cangzhou hospital of integrated TCM-WM Hebei	Cangzhou	Hebei	Recruiting
Harbin Medical University Cancer Hospital-Mammary gland of internal	Haerbin	Heilongjiang	Not Yet Recruiting
Henan Cancer Hospital	Zhengzhou	Henan	Not Yet Recruiting
The First Affiliated Hosipital Of Zhengzhou University	Zhengzhou	Henan	Not Yet Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	Not Yet Recruiting
Tongji Hospital Tongji Medical College of Hust	Wuhan	Hubei	Not Yet Recruiting
Hubei cancer hospital	Wuhan	Hubei	Not Yet Recruiting
Hunan Cancer Hospital	Changsha	Hunan	Not Yet Recruiting
Jiangsu province hospital	Nanjing	Jiangsu	Not Yet Recruiting
Wuxi People's Hospital	Wuxi	Jiangsu	Not Yet Recruiting
Jilin cancer hospital	Jilin City	Jilin	Not Yet Recruiting
The First Hospital Of China Medical University	Shenyang	Liaoning	Not Yet Recruiting
Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	Not Yet Recruiting
Shandong Cancer Hospital	Jinan	Shandong	Recruiting
LinYi Cancer Hospital	Linyi	Shandong	Not Yet Recruiting
The affiliated hospital of Qingdao university	Qingdao	Shandong	Not Yet Recruiting
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Not Yet Recruiting
Shanghai Pulmonary Hospital	Shanghai	Shanghai Municipality	Not Yet Recruiting
Shanxi province cancer hospital	Taiyuan	Shanxi	Not Yet Recruiting
The First Affiliated Hospital of Xi'An Jiaotong University	Xi’an	Shanxi	Not Yet Recruiting
Sichuan province cancer hospital	Chengdu	Sichuan	Not Yet Recruiting
West China Hospital Sichuan University	Chengdu	Sichuan	Not Yet Recruiting
Tianjin Medical University Cancer Institute Hospital	Tianjin	Tianjin Municipality	Not Yet Recruiting
The First affiliated hospital Zhejiang university school of medicine	Hangzhou	Zhejiang	Not Yet Recruiting
The Second Affiliated Hospital Zhejiang School of Medicine	Hangzhou	Zhejiang	Not Yet Recruiting
Taizhou Hospital Zhejiang Province	Taizhou	Zhejiang	Not Yet Recruiting

More Allist Pharmaceuticals, Inc. trials in China

Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion Active, not recruiting

A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases Recruiting

A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China Active, not recruiting

A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. Recruiting

Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation Recruiting

Other trials for the same condition

Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06416410 on ClinicalTrials.gov ↗ ← All trials in China