JMKX001899 combined with IN10018 and/or chemotherapy for advanced KRAS G12C non-small cell lung cancer

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.

This trial will test whether the experimental drug JMKX001899, given alone or with IN10018 and/or chemotherapy, is safe and shows signs of benefit for people with advanced non-small cell lung cancer that has the KRAS G12C mutation.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06946927 on ClinicalTrials.gov

What this trial studies

This Phase 1b trial uses dose-escalation and expansion cohorts to define safe dosing and to look for early signs of activity of JMKX001899 given in combination with IN10018, with chemotherapy (pemetrexed plus carboplatin), or with both IN10018 and chemotherapy in patients with locally advanced or metastatic NSCLC harboring KRAS G12C. Primary objectives include safety, tolerability, and pharmacokinetics, with secondary outcomes assessing tumor response by RECIST 1.1. Eligible participants must have measurable disease, ECOG performance status 0–1, adequate organ function, and meet specified washout periods from prior therapies. The trial is conducted at Guangdong Provincial People's Hospital in Guangzhou with standard phase 1 monitoring and dose‑limiting toxicity assessments guiding cohort decisions.

Who should consider this trial

Good fit: Adults with locally advanced or metastatic NSCLC that carries the KRAS G12C mutation, measurable disease, ECOG 0–1, adequate organ function, and the required washout from prior anticancer treatments are the intended candidates.

Not a fit: Patients with uncontrolled central nervous system or leptomeningeal disease, other actionable driver mutations, poor performance status (ECOG ≥2), recent anticancer therapy within protocol-specified washouts, or a recent other malignancy are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the combinations could provide a new treatment option that improves disease control for patients with KRAS G12C-mutant advanced NSCLC.

How similar studies have performed: Targeting KRAS G12C has led to approved drugs and clinical activity, and combining KRAS G12C-targeted agents with other targeted drugs or chemotherapy is an active area with some early positive signals but not yet definitive proof of superior outcomes.

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Yilong Wu — Guangdong Provincial People's Hospital
• Study coordinator: Jieting Zhao

Conditions NSCLC