NCT06946927 A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
| NCT ID | NCT06946927 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jemincare |
| Condition | NSCLC (Advanced Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-06-06 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease. 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: 1. Subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled. 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.
Contact & Investigator
Yilong Wu
PRINCIPAL INVESTIGATOR
Guangdong Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT06946927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying NSCLC (Advanced Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06946927 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06946927 currently recruiting?
Yes, NCT06946927 is actively recruiting participants. Contact the research team at zhaojieting@jemincare.com for enrollment information.
Where is the NCT06946927 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06946927 clinical trial?
NCT06946927 is sponsored by Jemincare. The principal investigator is Yilong Wu at Guangdong Provincial People's Hospital. The trial plans to enroll 72 participants.
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