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

Phase 3Not Yet RecruitingNCT07242274

Jemincare472 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

472

Conditions

NSCLC (Non-small Cell Lung Cancer)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PFS

Progression-Free Survival

Time frame: 1 year

Secondary Outcomes

Overall Survival

Time frame: 3 years

Adverse Event

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