NCT06946927

Brief Summary

This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Jun 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

April 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

July 1, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 21, 2025

Last Update Submit

June 26, 2025

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (2)

  • Recommended Phase II dose (RP2D)

    approximately 1 year

  • adverse events

    Through study completion, approximately 2.5 years

Study Arms (3)

Cohort A: JMKX001899+IN10018

EXPERIMENTAL
Drug: JMKX001899Drug: IN10018

Cohort B: JMKX001899+chemotherapy

EXPERIMENTAL
Drug: JMKX001899Drug: Chemotherapy: PemetrexedDrug: Carboplatin

Cohort C: JMKX001899+IN10018+chemotherapy

EXPERIMENTAL
Drug: JMKX001899Drug: IN10018Drug: Chemotherapy: PemetrexedDrug: Carboplatin

Interventions

JMKX001899DRUG

JMKX001899 tablet administered orally daily.

Cohort A: JMKX001899+IN10018Cohort B: JMKX001899+chemotherapyCohort C: JMKX001899+IN10018+chemotherapy
IN10018DRUG

IN10018 tablet administered orally daily.

Cohort A: JMKX001899+IN10018Cohort C: JMKX001899+IN10018+chemotherapy
Chemotherapy: PemetrexedDRUG

IV infusion once every 3 weeks

Cohort B: JMKX001899+chemotherapyCohort C: JMKX001899+IN10018+chemotherapy
CarboplatinDRUG

IV infusion once every 3 weeks, 4 Cycles

Cohort B: JMKX001899+chemotherapyCohort C: JMKX001899+IN10018+chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
  • Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
  • Measurable disease according to RECIST 1.1.
  • An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.

You may not qualify if:

  • Subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
  • Prior chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).
  • History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Yilong Wu

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieting Zhao

CONTACT

+86 13407649933zhaojieting@jemincare.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 27, 2025

Study Start

June 6, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

July 1, 2025

Record last verified: 2025-04

Locations

CN(1)