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

NCT ID: NCT07242274

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2029-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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NSCLC (Non-small Cell Lung Cancer)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JMKX001899

Orally, once daily

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

Orally, once daily

Docetaxel

By IV infusion every 21 days

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

By IV infusion every 21 days

Interventions

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JMKX001899

Orally, once daily

Intervention Type DRUG

Docetaxel

By IV infusion every 21 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jemincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Fawei Wu

Role: CONTACT

+86 15720614080

Facility Contacts

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Jie Wang, Doctor

Role: primary

+86 13910704669

Other Identifiers

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JY-JM1899-103

Identifier Type: -

Identifier Source: org_study_id

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