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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Yilong Wu — Guangdong Provincial People's Hospital
• Study coordinator: Jieting Zhao
• Email: zhaojieting@jemincare.com
• Phone: +86 13407649933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.