Not Yet RecruitingPhase 3

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

China472 participantsStarted 2025-12-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

PFS

Timeframe: 1 year

Trial details

NCT IDNCT07242274

SponsorJemincare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Fawei Wu

+86 15720614080 wufawei@jeyoupharma.com

View on ClinicalTrials.gov More NSCLC (Non-small Cell Lung Cancer) trials