A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
NCT ID: NCT06946927
Last Updated: 2025-07-01
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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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2025-06-06
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A: JMKX001899+IN10018
JMKX001899
JMKX001899 tablet administered orally daily.
IN10018
IN10018 tablet administered orally daily.
Cohort B: JMKX001899+chemotherapy
JMKX001899
JMKX001899 tablet administered orally daily.
Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Carboplatin
IV infusion once every 3 weeks, 4 Cycles
Cohort C: JMKX001899+IN10018+chemotherapy
JMKX001899
JMKX001899 tablet administered orally daily.
IN10018
IN10018 tablet administered orally daily.
Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Carboplatin
IV infusion once every 3 weeks, 4 Cycles
Interventions
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JMKX001899
JMKX001899 tablet administered orally daily.
IN10018
IN10018 tablet administered orally daily.
Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Carboplatin
IV infusion once every 3 weeks, 4 Cycles
Eligibility Criteria
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Inclusion Criteria
2. Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
3. Measurable disease according to RECIST 1.1.
4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
5. Adequate organ function.
Exclusion Criteria
2. 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).
3. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
4. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
18 Years
75 Years
ALL
No
Sponsors
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Jemincare
INDUSTRY
Responsible Party
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Principal Investigators
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Yilong Wu
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JMKX1899-C101
Identifier Type: -
Identifier Source: org_study_id
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