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
Phase 3Interventional Study
Non-Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
InxMed (Shanghai) Co., Ltd. · Industry
Who this trial is looking for
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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).
Trial Locations
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Eligibility Criteria
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 la…
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
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