Advanced Non-squamous Non-small-cell Lung CancerPhase 3NCT06416410
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
A Phase 3 study testing JAB-21822, Tislelizumab and JAB-3312 in people with Advanced Non-squamous Non-small-cell Lung Cancer and Metastatic Non-squamous Non Small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 37 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
- What is being tested?
- JAB-21822, Tislelizumab and JAB-3312
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 37 sitesChina
- Study dates
- 7 Aug 2024to Aug 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
China37 sites, 37 recruiting
- Not yet recruiting
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
- Recruiting
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, 100021
- Not yet recruiting
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, 100070
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
- Recruiting
Beijing Chest Hospital ,Capital Medical University
Beijing, Beijing Municipality, 101125
- Recruiting
Cangzhou hospital of integrated TCM-WM Hebei
Cangzhou, Hebei, 061000
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
- Not yet recruiting
Sichuan province cancer hospital
Chengdu, Sichuan, 610041
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610044
- Not yet recruiting
Fujian cancer Hospital
Fuzhou, Fujian, 350014
- Not yet recruiting
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Not yet recruiting
Harbin Medical University Cancer Hospital-Mammary gland of internal
Haerbin, Heilongjiang, 150081
- Not yet recruiting
The First affiliated hospital Zhejiang university school of medicine
Hangzhou, Zhejiang, 310003
- Not yet recruiting
The Second Affiliated Hospital Zhejiang School of Medicine
Hangzhou, Zhejiang, 310003
- Not yet recruiting
Anhui Province cancer hospital
Hefei, Anhui, 230031
- Not yet recruiting
Jilin cancer hospital
Jilin City, Jilin, 130021
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250012
- Not yet recruiting
LinYi Cancer Hospital
Linyi, Shandong, 276002
- Not yet recruiting
Jiangsu province hospital
Nanjing, Jiangsu, 210029
- Not yet recruiting
Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
Nanning, Guangxi, 530000
- Not yet recruiting
The affiliated hospital of Qingdao university
Qingdao, Shandong, 266003
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
- Not yet recruiting
The First Hospital Of China Medical University
Shenyang, Liaoning, 110001
- Not yet recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
- Not yet recruiting
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, 518116
- Not yet recruiting
Shanxi province cancer hospital
Taiyuan, Shanxi, 030013
- Not yet recruiting
Taizhou Hospital Zhejiang Province
Taizhou, Zhejiang, 317000
- Not yet recruiting
Tianjin Medical University Cancer Institute Hospital
Tianjin, Tianjin Municipality, 300181
- Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
- Not yet recruiting
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, 430030
- Not yet recruiting
Hubei cancer hospital
Wuhan, Hubei, 430079
- Not yet recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
- Not yet recruiting
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, 710061
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
- Not yet recruiting
The First Affiliated Hosipital Of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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
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
- Being tested
- JAB-21822, Tislelizumab, JAB-3312, Pemetrexed, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-21822Drug
JAB-21822 administered orally as a tablet
TislelizumabDrug
Tislelizumab administered as an intravenous (IV) infusion
JAB-3312Drug
JAB-3312 administered orally as a tablet or capsule
PemetrexedDrug
Pemetrexed administered as an intravenous (IV) infusion
CarboplatinDrug
Carboplatin administered as an intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| JAB-21822+JAB-3312 | Experimental | JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle Receives: 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 Receives: Drug: Tislelizumab; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Baseline up to 4 years
Secondary outcomes (6)
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
Measured: From Baseline up to 4 years
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause
Measured: From Baseline up to 4 years
Number of Participants With Treatment-Emergent Adverse Events
Measured: From Baseline up to 4 years
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: From Baseline up to 4 years
Time to Maximum Plasma Concentration (Tmax)
Measured: Pre-dose Day 1 up to Day 64
Half life (t1/2)
Measured: Pre-dose Day 1 up to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start7 Aug 2024
- Primary completion30 Sep 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Jie M.D., Principal investigator, Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416410
- Sponsor's protocol ID
- JAB-21822-3002
- Status last verified
- Aug 2026
- First submitted
- 9 May 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06416410
- Acronym / sponsor ID
- JAB-21822-3002
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAB-21822+JAB-3312 | Experimental | Drug: JAB-21822, Drug: JAB-3312JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle |
| Tislelizumab combined with Pemetrexed + Carboplatin | Active comparator | Drug: Tislelizumab, Drug: Pemetrexed, Drug: CarboplatinTislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-21822JAB-21822 administered orally as a tablet | Drug | JAB-21822+JAB-3312 |
| TislelizumabTislelizumab administered as an intravenous (IV) infusion | Drug | Tislelizumab combined with Pemetrexed + Carboplatin |
| JAB-3312JAB-3312 administered orally as a tablet or capsule | Drug | JAB-21822+JAB-3312 |
| PemetrexedPemetrexed administered as an intravenous (IV) infusion | Drug | Tislelizumab combined with Pemetrexed + Carboplatin |
| CarboplatinCarboplatin administered as an intravenous (IV) infusion | Drug | Tislelizumab combined with Pemetrexed + Carboplatin |
Primary outcome
Outcome Progression-free Survival (PFS)
Time frame: 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).
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: From Baseline up to 4 years
Overall Survival (OS)
Time frame: From Baseline up to 4 years
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From Baseline up to 4 years
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From Baseline up to 4 years
Time to Maximum Plasma Concentration (Tmax)
Time frame: Pre-dose Day 1 up to Day 64
Half life (t1/2)
Time frame: Pre-dose Day 1 up to Day 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wang Jie M.D. principal investigator
Cancer Institute and Hospital
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JAB-21822, Tislelizumab and JAB-3312 in people with Advanced Non-squamous Non-small-cell Lung Cancer and Metastatic Non-squamous Non Small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 37 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanghai Allist Pharmaceuticals Co., Ltd (021-80423288, zhenhua.gong@allist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Progression-free Survival (PFS) (time frame: From Baseline up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.