Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC
NCT ID: NCT07242274
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
472 participants
INTERVENTIONAL
2025-12-31
2029-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JMKX001899
Orally, once daily
JMKX001899
Orally, once daily
Docetaxel
By IV infusion every 21 days
Docetaxel
By IV infusion every 21 days
Interventions
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JMKX001899
Orally, once daily
Docetaxel
By IV infusion every 21 days
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed NSCLC.
3. 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.
4. At least one measurable lesion as defined by RECIST version 1.1.
Exclusion Criteria
2. Previous treatment with any KRAS G12C-targeted agent.
3. Prior docetaxel therapy in the locally advanced/metastatic setting.
18 Years
ALL
No
Sponsors
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Jemincare
INDUSTRY
Responsible Party
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Principal Investigators
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Jie Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JY-JM1899-103
Identifier Type: -
Identifier Source: org_study_id
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