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NCT Number: NCT06946927

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

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.

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Key information

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Yilong Wu

CONTACT

[email protected]

020-83525210

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JMKX001899

Drug

JMKX001899 tablet administered orally daily.

IN10018

Drug

IN10018 tablet administered orally daily.

Chemotherapy: Pemetrexed

Drug

IV infusion once every 3 weeks

carboplatin

Drug

IV infusion once every 3 weeks, 4 Cycles

Primary outcomes

  1. Recommended Phase II dose (RP2D)

    Time frame: approximately 1 year

  2. adverse events

    Time frame: Through study completion, approximately 2.5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jieting Zhao

CONTACT

[email protected]

+86 13407649933

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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