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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JMKX001899

    Drug

    Orally, once daily

  • Docetaxel

    Drug

    By IV infusion every 21 days

Treatment groups

472 Participants
are divided into 2 treatment groups
Group A: JMKX001899Experimental treatment 1 intervention
Group B: DocetaxelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression-Free Survival

Time frame
1 year

Secondary outcomes

1

OS

Overall Survival

Time frame
3 years
2

AE

Adverse Event

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: