NCT07833202Not yet recruitingPhase 3
A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 416 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07833202
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 416
- From Oct 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has another known driver mutation with approved first-line targeted therapy.
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
Other illness
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
- Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.
- Any condition that, in the opinion of the Investigator, would interfere with participation or study results
Other
- Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
Who the study is looking for
- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
- Has KRAS G12C mutation confirmed by central laboratory.
- Measurable disease according to RECIST 1.1.
- An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Life expectancy ≥3 months in the opinion of the Investigator
- Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.