Clinical trial Recruiting at 6 sites Phase 3 Interventional Ages 18 and up

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.

More Metastatic Non Small Cell Lung Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment392 (estimated)
SponsorAllist Pharmaceuticals, Inc.
Industry-sponsored
Drugs / interventionstislelizumab
Locations37 sites (Hefei, Anhui and 36 other locations)
StatusRecruiting
StartedAugust 7, 2024
Main results expectedSeptember 30, 2029
Study endsAugust 2030
Registry record updatedAugust 13, 2026
Trial IDNCT06416410 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.