Combining JAB-21822 and JAB-3312 for advanced lung cancer with KRAS mutation
Official title: 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
Run by Allist Pharmaceuticals, Inc. · NCT06416410 · Data updated 2026-11-12
This study is testing if a new combination of JAB-21822 and JAB-3312 can help people with advanced lung cancer that has a specific KRAS mutation do better than the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 392 (estimated) |
| Sponsor | Allist Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | tislelizumab |
| Locations | 37 sites (Hefei, Anhui and 36 other locations) |
| Status | Recruiting |
| Started | August 7, 2024 |
| Main results expected | September 30, 2029 |
| Study ends | August 2030 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06416410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with confirmed KRAS p.G12C mutated advanced or metastatic non-squamous NSCLC who have not received prior systemic therapy.
✕Probably not a fit
Patients with other driver gene mutations that have available targeted therapies or those with untreated central nervous system metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 study evaluates the effectiveness of a combination of JAB-21822 and JAB-3312 compared to standard treatment with tislelizumab, pemetrexed, and carboplatin for patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS p.G12C mutation. The trial aims to determine if this new combination can provide better outcomes than the current standard of care. Participants will be monitored for their response to treatment and any side effects experienced during the study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced lung cancer and KRAS mutations.
How similar studies have gone: Other studies targeting KRAS mutations have shown promise, but this specific combination approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China Recruiting -
Beijing Cancer Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting -
Beijing Chest Hospital ,Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
Cangzhou hospital of integrated TCM-WM Hebei
Cangzhou, Hebei, China Recruiting -
Shandong Cancer Hospital
Jinan, Shandong, China Recruiting
Show 31 more locations
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Anhui Province cancer hospital
Hefei, Anhui, China Not yet recruiting -
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, China Not yet recruiting -
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China Not yet recruiting -
Fujian cancer Hospital
Fuzhou, Fujian, China Not yet recruiting -
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Not yet recruiting -
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, China Not yet recruiting -
Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
Nanning, Guangxi, China Not yet recruiting -
Harbin Medical University Cancer Hospital-Mammary gland of internal
Haerbin, Heilongjiang, China Not yet recruiting -
Henan Cancer Hospital
Zhengzhou, Henan, China Not yet recruiting -
The First Affiliated Hosipital Of Zhengzhou University
Zhengzhou, Henan, China Not yet recruiting -
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China Not yet recruiting -
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China Not yet recruiting -
Hubei cancer hospital
Wuhan, Hubei, China Not yet recruiting -
Hunan Cancer Hospital
Changsha, Hunan, China Not yet recruiting -
Jiangsu province hospital
Nanjing, Jiangsu, China Not yet recruiting -
Wuxi People's Hospital
Wuxi, Jiangsu, China Not yet recruiting -
Jilin cancer hospital
Jilin City, Jilin, China Not yet recruiting -
The First Hospital Of China Medical University
Shenyang, Liaoning, China Not yet recruiting -
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China Not yet recruiting -
LinYi Cancer Hospital
Linyi, Shandong, China Not yet recruiting -
The affiliated hospital of Qingdao university
Qingdao, Shandong, China Not yet recruiting -
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Not yet recruiting -
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China Not yet recruiting -
Shanxi province cancer hospital
Taiyuan, Shanxi, China Not yet recruiting -
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, China Not yet recruiting -
Sichuan province cancer hospital
Chengdu, Sichuan, China Not yet recruiting -
West China Hospital Sichuan University
Chengdu, Sichuan, China Not yet recruiting -
Tianjin Medical University Cancer Institute Hospital
Tianjin, Tianjin Municipality, China Not yet recruiting -
The First affiliated hospital Zhejiang university school of medicine
Hangzhou, Zhejiang, China Not yet recruiting -
The Second Affiliated Hospital Zhejiang School of Medicine
Hangzhou, Zhejiang, China Not yet recruiting -
Taizhou Hospital Zhejiang Province
Taizhou, Zhejiang, China Not yet recruiting
Study contacts
- Principal investigator: Wang Jie M.D. — Cancer Institute and Hospital
- Study coordinator: Shanghai Allist Pharmaceuticals Co., Ltd
- Email: zhenhua.gong@allist.com.cn
- Phone: 021-80423288
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.