NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1NCT06946927
A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
A Phase 1 study testing JMKX001899, IN10018 and Chemotherapy: Pemetrexed in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Jemincare at 1 site in China.
Trial summary
This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- JMKX001899, IN10018 and Chemotherapy: 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
- 72 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2025to Dec 2027
- Phase
- Phase 1
- 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 NSCLC disease.
- Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
- Measurable disease according to RECIST 1.1.
- An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Who cannot join
- Subjects 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 chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).
- 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.
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, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yilong Wu, 020-83525210, syylwu@live.cn
About this study
Official title: A Phase Ib, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of JMKX001899 in Combination With Other Therapies in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation.
This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.
- Being tested
- JMKX001899, IN10018, Chemotherapy: Pemetrexed, Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX001899Drug
JMKX001899 tablet administered orally daily.
IN10018Drug
IN10018 tablet administered orally daily.
Chemotherapy: PemetrexedDrug
IV infusion once every 3 weeks
CarboplatinDrug
IV infusion once every 3 weeks, 4 Cycles
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: JMKX001899+IN10018 | Experimental | Not described Receives: Drug: JMKX001899; Drug: IN10018 |
| Cohort B: JMKX001899+chemotherapy | Experimental | Not described Receives: Drug: JMKX001899; Drug: Chemotherapy: Pemetrexed; Drug: Carboplatin |
| Cohort C: JMKX001899+IN10018+chemotherapy | Experimental | Not described Receives: Drug: JMKX001899; Drug: IN10018; Drug: Chemotherapy: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II dose (RP2D)
Measured: approximately 1 year
adverse events
Measured: Through study completion, approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start6 Jun 2025
- Primary completionFeb 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by JemincareThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946927
- Sponsor's protocol ID
- JMKX1899-C101
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of JMKX001899 in Combination With Other Therapies in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation.
- ClinicalTrials.gov ID
- NCT06946927
- Acronym / sponsor ID
- JMKX1899-C101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Apr 2025 (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 phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: JMKX001899+IN10018 | Experimental | Drug: JMKX001899, Drug: IN10018 |
| Cohort B: JMKX001899+chemotherapy | Experimental | Drug: JMKX001899, Drug: Chemotherapy: Pemetrexed, Drug: Carboplatin |
| Cohort C: JMKX001899+IN10018+chemotherapy | Experimental | Drug: JMKX001899, Drug: IN10018, Drug: Chemotherapy: Pemetrexed, Drug: Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
- Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
- Measurable disease according to RECIST 1.1.
- An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Key exclusion criteria (4 listed)
- Subjects 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 chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).
- 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 |
|---|---|---|
| JMKX001899JMKX001899 tablet administered orally daily. | Drug | Cohort A: JMKX001899+IN10018, Cohort B: JMKX001899+chemotherapy, Cohort C: JMKX001899+IN10018+chemotherapy |
| IN10018IN10018 tablet administered orally daily. | Drug | Cohort A: JMKX001899+IN10018, Cohort C: JMKX001899+IN10018+chemotherapy |
| Chemotherapy: PemetrexedIV infusion once every 3 weeks | Drug | Cohort B: JMKX001899+chemotherapy, Cohort C: JMKX001899+IN10018+chemotherapy |
| CarboplatinIV infusion once every 3 weeks, 4 Cycles | Drug | Cohort B: JMKX001899+chemotherapy, Cohort C: JMKX001899+IN10018+chemotherapy |
Primary outcome
Recommended Phase II dose (RP2D)
Time frame: approximately 1 year
adverse events
Time frame: Through study completion, approximately 2.5 years
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 1 Jul 2025.
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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.
Yilong Wu principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX001899, IN10018 and Chemotherapy: Pemetrexed in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Jemincare 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 5 inclusion and 4 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 1 Jul 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (+86 13407649933, zhaojieting@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II dose (RP2D) (time frame: approximately 1 year). The study lists 2 primary outcomes in all. 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 1 Jul 2025.