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

NCT07242274 · tracked via the Priya Life Science China tracker

Sponsor

Jemincare

Phase

Phase 3

Started

2025-12-31

Last updated

2025-11-21

Condition(s) studied

NSCLC (Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

JMKX001899Docetaxel

JMKX001899: Orally, once daily

Docetaxel: By IV infusion every 21 days

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically or cytologically confirmed NSCLC. 3. 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. 4. At least one measurable lesion as defined by RECIST version 1.1. Exclusion Criteria: 1. Known concomitant presence of other oncogenic driver mutations or rearrangements with established targeted therapies . 2. Previous treatment with any KRAS G12C-targeted agent. 3. Prior docetaxel therapy in the locally advanced/metastatic setting.

Primary outcome measure(s)

PFS — 1 year
Progression-Free Survival

Trial sites (1)

Facility	City	Region	Status
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China	Beijing	Beijing Municipality

More Jemincare trials in China

Trial of JYB1904 in Chronic Spontaneous Urticaria. Recruiting

A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors Recruiting

Trial of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) Recruiting

Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia Recruiting

A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion Recruiting

Other trials for the same condition

Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC Recruiting

Stereotactic Body Radiotherapy With Sequential Iparomlimab and Tuvonralimab (QL1706) + Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-small-cell Lung Cancer in China (LUNG-Nanjing01): a Single-arm, Single-centre, Phase 2 Trial Starting soon

Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer Recruiting

Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC Recruiting

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07242274 on ClinicalTrials.gov ↗ ← All trials in China