AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - 80 YearsAllInxMed (Shanghai) Co., Ltd.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ3 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
๐Ÿ’Š

What it tests

  • IN10018 in combination with D-1553
  • anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed
๐Ÿ“

Where

11 sites
Beijing Cancer Hospital
Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Union Hospital Tongji Medidcal College Huazhong University of Science and Technology
Wuhan, China
Hunan Cancer Hospital
Changsha, China
Jiangsu Cancer Hospital
Nanjing, China
First Affiliated Hospital of Gannan Medical University
Gannan, China

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy