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Luciann Nguyen
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NCT07174908phase 3recruiting

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

InxMed (Shanghai) Co., Ltd.

ClinicalTrials.gov
400
Enrollment · estimated
1
Countries · 11 sites
2028-09
Primary completion
6 mo ago
Record updated
Commercial relevance

Trial record references molecular eligibility required, central lab testing referenced.

Molecular eligibility requiredCentral lab testing
Biomarker requirement language
  • Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
  • Has KRAS G12C mutation confirmed by central laboratory
Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial
  • New trial
    59/100
    Opportunity

    New phase 3 trial NCT07174908 posted by InxMed (Shanghai) Co., Ltd.: "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".

    ClinicalTrials.gov record updated 189 days ago.

Eligibility — raw, for validation
Inclusion Criteria:

* 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 Criteria:

* 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