Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC
A Multicenter, Randomized, Open-Label, Phase 3 Study Evaluating the Efficacy and Safety of JMKX001899 Versus Docetaxel in Previously Treated Patients With KRAS G12C-Mutant Advanced or Metastatic Non-Small Cell Lung Cancer
1 other identifier
interventional
472
1 country
1
Brief Summary
This is a multicenter, randomized, open-label, phase 3 clinical trial designed to evaluate the efficacy and safety of JMKX001899 compared to docetaxel in patients with previously treated, KRAS G12C-mutant advanced or metastatic non-small cell lung cancer (NSCLC). KRAS G12C mutation is present in a subset of NSCLC patients. While docetaxel is a standard chemotherapy option, JMKX001899 is an investigational, targeted therapy designed to selectively inhibit the KRAS G12C mutation. This trial aims to determine whether JMKX001899 offers a superior clinical benefit compared to standard chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2025
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 21, 2025
CompletedStudy Start
First participant enrolled
December 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
November 21, 2025
November 1, 2025
2 years
November 17, 2025
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
Progression-Free Survival
1 year
Secondary Outcomes (2)
OS
3 years
AE
from first dose to 28 days after the last dose
Study Arms (2)
JMKX001899
EXPERIMENTALOrally, once daily
Docetaxel
ACTIVE COMPARATORBy IV infusion every 21 days
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Histologically or cytologically confirmed NSCLC.
- Failure of at least one prior line of therapy for locally advanced/metastatic disease, that included a platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
- At least one measurable lesion as defined by RECIST version 1.1.
You may not qualify if:
- Known concomitant presence of other oncogenic driver mutations or rearrangements with established targeted therapies .
- Previous treatment with any KRAS G12C-targeted agent.
- Prior docetaxel therapy in the locally advanced/metastatic setting.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jemincarelead
Study Sites (1)
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Wang, Doctor
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 21, 2025
Study Start
December 31, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 30, 2029
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share