IN10018 plus D-1553 versus anti-PD-1 and chemotherapy for first-line KRAS G12C non-squamous NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open‑label Phase 3 trial comparing the combination of IN10018 and D‑1553 to standard first‑line anti‑PD‑1 therapy plus platinum and pemetrexed in patients with untreated, locally advanced or metastatic non‑squamous NSCLC harboring KRAS G12C. Patients must have centrally confirmed KRAS G12C mutation, measurable disease, and ECOG 0–1 to enroll. The investigational combination is supported by preclinical data suggesting synergistic antitumor effects through FAK‑YAP pathway suppression, reduced stromal fibrosis, and induction of immunogenic cell death, and by early-phase clinical signals of activity and tolerability. Primary outcomes will focus on efficacy and safety compared with current standard chemo‑immunotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Union Hospital Tongji Medidcal College Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Jiangsu Cancer Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Zhengbo Song Professor, Doctor — Zhejiang Cancer Hospital
• Study coordinator: Shu Fang Project Manager, bachelor
• Email: shu.fang@inxmed.com
• Phone: 86-15933968623

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.