NSCLCPhase 3NCT07833202
A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
A Phase 3 study testing Sosimerasib in combination with IN10018 and Tislelizumab + Carboplatin + Pemetrexed in people with NSCLC, run by Shanghai Jeyou Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Sosimerasib in combination with IN10018 and Tislelizumab + Carboplatin + Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
- Has KRAS G12C mutation confirmed by central laboratory.
- Measurable disease according to RECIST 1.1.
- An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Life expectancy ≥3 months in the opinion of the Investigator
- Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment
Who cannot join
- Has another known driver mutation with approved first-line targeted therapy.
- Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
- Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.
- Any condition that, in the opinion of the Investigator, would interfere with participation or study results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Anwen Liu, 0791-86260752, awliu666@163.com
Anwen Liu
About this study
Official title: A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.
- Conditions
- NSCLC
- Being tested
- Sosimerasib in combination with IN10018, Tislelizumab + Carboplatin + Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sosimerasib in combination with IN10018Drug
Participants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity
Tislelizumab + Carboplatin + PemetrexedDrug
Participants receive Tislelizumab Q3W IV until disease progression or up to 2 years, plus Carboplatin Q3W IV for up to 4 cycles, plus Pemetrexed Q3W IV until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Sosimerasib in combination with IN10018 Receives: Drug: Sosimerasib in combination with IN10018 |
| Control Arm | Active comparator | anti-PD-1 monoclonal antibody in combination with chemotherapy Receives: Drug: Tislelizumab + Carboplatin + Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
Measured: 30 months
Secondary outcomes (8)
Objective Response Rate (ORR)
Defined as complete response (PR) + partial response (PR) assessed per RECIST v1.1 by BICR
Measured: 30 months
Overall Survival (OS)
Defined as time from randomization to death by any cause
Measured: up to 60 months
Disease Control Rate (DCR)
Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR
Measured: 30 months
Duration of Response (DoR)
Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first, assessed per RECIST v1.1 by BICR
Measured: 30 months
PFS by investigator assessment
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by investigator assessment.
Measured: up to 30 months
Number of participants with adverse event
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Measured: 30 months
Patient-reported outcome (PRO) questionnaire including EORTC QLQ-C30
Reports of health status directly from participants
Measured: up to 30 months
Patient-reported outcome (PRO) questionnaire including EORTC QLQ-LC13.
Reports of health status directly from participants
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833202
- Sponsor's protocol ID
- JMKX1899-C301
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT07833202
- Acronym / sponsor ID
- JMKX1899-C301
- Conditions
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 22 Sep 2026 (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 is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: Sosimerasib in combination with IN10018Sosimerasib in combination with IN10018 |
| Control Arm | Active comparator | Drug: Tislelizumab + Carboplatin + Pemetrexedanti-PD-1 monoclonal antibody in combination with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
- Has KRAS G12C mutation confirmed by central laboratory.
- Measurable disease according to RECIST 1.1.
- An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Key exclusion criteria (7 listed)
- Has another known driver mutation with approved first-line targeted therapy.
- Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
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 |
|---|---|---|
| Sosimerasib in combination with IN10018Participants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity | Drug | Study Arm |
| Tislelizumab + Carboplatin + PemetrexedParticipants receive Tislelizumab Q3W IV until disease progression or up to 2 years, plus Carboplatin Q3W IV for up to 4 cycles, plus Pemetrexed Q3W IV until disease progression. | Drug | Control Arm |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 30 months
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: 30 months
Overall Survival (OS)
Time frame: up to 60 months
Disease Control Rate (DCR)
Time frame: 30 months
Duration of Response (DoR)
Time frame: 30 months
PFS by investigator assessment
Time frame: up to 30 months
Number of participants with adverse event
Time frame: 30 months
Patient-reported outcome (PRO) questionnaire including EORTC QLQ-C30
Time frame: up to 30 months
Patient-reported outcome (PRO) questionnaire including EORTC QLQ-LC13.
Time frame: up to 30 months
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 24 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sosimerasib in combination with IN10018 and Tislelizumab + Carboplatin + Pemetrexed in people with NSCLC, run by Shanghai Jeyou Pharmaceutical Co., Ltd. at 1 site 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 7 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jieting Zhao (021-60198525, zhaojieting@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 30 months). 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 24 Sep 2026.