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NCT Number: NCT07242274

Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC

This is a multicenter, randomized, open-label, phase 3 clinical trial designed to evaluate the efficacy and safety of JMKX001899 compared to docetaxel in patients with previously treated, KRAS G12C-mutant advanced or metastatic non-small cell lung cancer (NSCLC).

KRAS G12C mutation is present in a subset of NSCLC patients. While docetaxel is a standard chemotherapy option, JMKX001899 is an investigational, targeted therapy designed to selectively inhibit the KRAS G12C mutation. This trial aims to determine whether JMKX001899 offers a superior clinical benefit compared to standard chemotherapy.

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Key information

Conditions

NSCLC (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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Beijing, Beijing Municipality, 100021, China

Location contact

Jie Wang, Doctor

CONTACT

[email protected]

+86 13910704669

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Histologically or cytologically confirmed NSCLC.
  • Failure of at least one prior line of therapy for locally advanced/metastatic disease, that included a platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
  • At least one measurable lesion as defined by RECIST version 1.1.

Exclusion criteria

  • Known concomitant presence of other oncogenic driver mutations or rearrangements with established targeted therapies .
  • Previous treatment with any KRAS G12C-targeted agent.
  • Prior docetaxel therapy in the locally advanced/metastatic setting.

Treatment and study plan

JMKX001899

Drug

Orally, once daily

docetaxel

Drug

By IV infusion every 21 days

Primary outcomes

  1. PFS

    Time frame: 1 year

    Progression-Free Survival

Secondary outcomes

  1. OS

    Time frame: 3 years

    Overall Survival

  2. AE

    Time frame: from first dose to 28 days after the last dose

    Adverse Event

Study contacts

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

Fawei Wu

CONTACT

[email protected]

+86 15720614080

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-Label, Phase 3 Study Evaluating the Efficacy and Safety of JMKX001899 Versus Docetaxel in Previously Treated Patients With KRAS G12C-Mutant Advanced or Metastatic Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Nov 21, 2025
Registry last updated
Nov 21, 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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