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

Jemincare

Status and phase: Not yet enrolling; Phase 3

Conditions: NSCLC (Non-small Cell Lung Cancer)

Treatments: Drug: Docetaxel; Drug: JMKX001899

Study type: Interventional

Funder types: Industry

Identifiers

NCT07242274

JY-JM1899-103

Details and patient eligibility

About

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.

Enrollment: 472 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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472 participants in 2 patient groups

JMKX001899

Experimental group

Description:

Orally, once daily

Treatment:

Drug: JMKX001899

Docetaxel

Active Comparator group

Description:

By IV infusion every 21 days

Treatment:

Drug: Docetaxel