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
Recruiting now · Phase 3
Conditions studied: Non-Small Cell Lung Cancer
In brief
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).
Key facts
- Study ID
- NCT07174908
- Run by
- InxMed (Shanghai) Co., Ltd.
- People needed
- 400
- Starts
- 2025-09-10
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able and willing to provide informed consent and comply with study requirements
- Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
- Aged 18-80 years at the time of consent
- Has KRAS G12C mutation confirmed by central laboratory
- Has not received prior systemic therapy for advanced or metastatic NSCLC
- Has at least one measurable lesion per RECIST v1.1
- ECOG performance status of 0-1
- Has adequate organ function
- Life expectancy ≥3 months in the opinion of the Investigator
- Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment
You may not qualify if…
- Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)
- Has active or untreated CNS metastases or carcinomatous meningitis
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
- Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)
- Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy
- Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ)
- Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable)
- Has known active hepatitis B, hepatitis C, or HIV infection
- Has received a live vaccine within 30 days before first dose of study drug
- Pregnant or breastfeeding women
- Has psychiatric or substance abuse disorders that would interfere with study compliance
- Is participating in another interventional clinical study
- Any condition that, in the opinion of the Investigator, would interfere with participation or study results
Where it is running
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
- Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
- Union Hospital Tongji Medidcal College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (enrolling)
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
- Hunan Cancer Hospital — Changsha, Hunan, China
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
- First Affiliated Hospital of Gannan Medical University — Gannan, Jiangxi, China
Full record on ClinicalTrials.gov
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