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Recruiting NCT06946927

A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation

Phase I Interventional NSCLC (Advanced Non-small Cell Lung Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JMKX001899, IN10018, Chemotherapy: Pemetrexed, Carboplatin.
Who it may be relevant to
Registry conditions: NSCLC (Advanced Non-small Cell Lung Cancer). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Drug JMKX001899
    JMKX001899 tablet administered orally daily.
  • Drug IN10018
    IN10018 tablet administered orally daily.
  • Drug Chemotherapy: Pemetrexed
    IV infusion once every 3 weeks
  • Drug Carboplatin
    IV infusion once every 3 weeks, 4 Cycles

Primary outcome measures

  • Recommended Phase II dose (RP2D) [Time frame: approximately 1 year]
  • adverse events [Time frame: Through study completion, approximately 2.5 years]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
  • Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
  • Measurable disease according to RECIST 1.1.
  • An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.

Exclusion criteria

  • 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.
  • 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).
  • History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT06946927 · JMKX1899-C101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗