NCT07174908 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
| NCT ID | NCT07174908 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | InxMed (Shanghai) Co., Ltd. |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-09-10 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Zhengbo Song Professor, Doctor
PRINCIPAL INVESTIGATOR
Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT07174908 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07174908 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07174908 currently recruiting?
Yes, NCT07174908 is actively recruiting participants. Contact the research team at shu.fang@inxmed.com for enrollment information.
Where is the NCT07174908 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Zhengzhou, China, Zhengzhou, China and 7 additional locations.
Who is sponsoring the NCT07174908 clinical trial?
NCT07174908 is sponsored by InxMed (Shanghai) Co., Ltd.. The principal investigator is Zhengbo Song Professor, Doctor at Zhejiang Cancer Hospital. The trial plans to enroll 400 participants.
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