Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JMKX001899, Docetaxel.
- Who it may be relevant to
- Registry conditions: NSCLC (Non-small Cell Lung Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug JMKX001899
Orally, once daily - Drug Docetaxel
By IV infusion every 21 days
Primary outcome measures
- PFS [Time frame: 1 year]
Secondary outcome measures (2)
- OS [Time frame: 3 years]
- AE [Time frame: from first dose to 28 days after the last dose]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China — Beijing
Identifiers
NCT: NCT07242274 · JY-JM1899-103