A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation

Phase 1

Not yet recruiting

• Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
• Interventions: Drug: JMKX001899; Drug: IN10018; Drug: Carboplatin

• Registration Number: NCT06946927
• Lead Sponsor: Jemincare

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-06
• Primary Completion: 2026-02
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. 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).
3. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
4. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort A: JMKX001899+IN10018	JMKX001899	-
Cohort B: JMKX001899+chemotherapy	JMKX001899	-
Cohort C: JMKX001899+IN10018+chemotherapy	Carboplatin	-
Cohort A: JMKX001899+IN10018	IN10018	-
Cohort B: JMKX001899+chemotherapy	Carboplatin	-
Cohort C: JMKX001899+IN10018+chemotherapy	JMKX001899	-
Cohort C: JMKX001899+IN10018+chemotherapy	IN10018	-

Primary Outcome Measures

Name	Time	Method
Recommended Phase II dose (RP2D)	approximately 1 year
adverse events	Through study completion, approximately 2.5 years

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China