Clinical trial · Interventional
Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| JMKX001899 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JMKX001899
- description
- Orally, once daily
- interventionNames
- Drug: JMKX001899
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- By IV infusion every 21 days
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 1 year
- description
- Progression-Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available