Actively Recruiting
A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2026-03-03
400
Participants Needed
11
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).
CONDITIONS
Official Title
A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent and comply with study requirements
- Histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
- Age between 18 and 80 years at time of consent
- KRAS G12C mutation confirmed by central laboratory
- No prior systemic therapy for advanced or metastatic NSCLC
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0-1
- Adequate organ function
- Life expectancy of at least 3 months as judged by the Investigator
- Male and female subjects of reproductive potential agree to use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Other histological NSCLC subtypes such as small cell or neuroendocrine
- Active or untreated CNS metastases or carcinomatous meningitis
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
- Presence of another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)
- Uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy
- History of another malignancy within 5 years, except curatively treated low-risk cancers (e.g., basal cell carcinoma, cervical carcinoma in situ)
- Gastrointestinal conditions that may interfere with oral drug absorption
- Known active hepatitis B, hepatitis C, or HIV infection
- Receipt of live vaccine within 30 days before first study drug dose
- Pregnant or breastfeeding women
- Psychiatric or substance abuse disorders interfering with study compliance
- Participation in another interventional clinical study
- Any condition that may interfere with participation or study results as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
3
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
5
Union Hospital Tongji Medidcal College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
7
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
8
First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, China
Not Yet Recruiting
9
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
10
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
11
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
S
Shu Fang Project Manager, bachelor
CONTACT
J
Jack Zhang Clinical Trial Manager, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here