Actively Recruiting
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
Led by Jemincare · Updated on 2025-07-01
72
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of JMKX001899 combined with IN10018, chemotherapy, or both in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has the KRAS G12C mutation. This phase 1b study aims to find the right dose and assess how well these combinations work together in this specific patient group. Participants will be assigned to one of three study groups: JMKX001899 with IN10018, JMKX001899 with chemotherapy (Pemetrexed and Carboplatin), or JMKX001899 with both IN10018 and chemotherapy. JMKX001899 and IN10018 are taken daily as oral tablets, while chemotherapy drugs are given by intravenous infusion every 3 weeks for up to 4 cycles. The study includes dose escalation and expansion phases to evaluate different dosing levels and combinations. During the study, participants will undergo regular assessments to monitor side effects and measure the recommended dose for phase II. Researchers will track adverse events throughout the study, which may last about 2.5 years. Evaluations will include measuring disease response using RECIST 1.1 criteria and monitoring organ function and performance status. The study follows participants closely to understand treatment effects and safety.
CONDITIONS
Brief Title
A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed Stage IIIB, IIIC, or IV NSCLC not suitable for surgery or definitive chemoradiation
- Presence of KRAS G12C mutation and negative for other driver genes with approved targeted therapies
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Adequate organ function as determined by study assessments
You will not qualify if you...
- Presence of carcinomatous meningitis or spinal cord compression, or uncontrolled central nervous system (CNS) or leptomeningeal metastases
- Receipt of chemotherapy, radiotherapy, immunotherapy, or investigational treatment within 4 weeks prior to study drug (6 weeks for nitrosoureas or mitomycin C; 2 weeks for small molecule targeted therapies or traditional anticancer medicines)
- History of other malignancies within the past 3 years, except for those treated with curative intent
- Gastrointestinal conditions that prevent oral medication intake or affect drug absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 1 year
Participants receive oral tablets of JMKX001899 daily, combined with either IN10018 tablets daily, chemotherapy (Pemetrexed and Carboplatin) every 3 weeks for 4 cycles, or both, depending on their assigned cohort.
Regular visits for treatment administration and monitoring according to cohort
Duration - Up to approximately 1.5 years after treatment
Participants are monitored for safety and adverse events after treatment completion.
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
J
Jieting Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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