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

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.

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.