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
A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
InxMed (Shanghai) Co., Ltd.
400 participants
Sep 10, 2025
INTERVENTIONAL
Summary
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).
Eligibility
Inclusion Criteria10
- 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
Exclusion Criteria13
- 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
Interventions
IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle
Tislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg/mL/min or Cisplatin 75mg/m² Q3W IV+ Pemetrexed 500mg/m² Q3W IV
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT07174908