Sosimerasib with IN10018 compared with standard treatment for first-time KRAS G12C lung cancer
Compares sosimerasib plus IN10018 with standard drugs in untreated KRAS G12C non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Nanchang, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-squamous non-small cell lung cancer that has a KRAS G12C mutation and has not been treated before.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Stage IIIB or IIIC that cannot be removed by surgery or treated with definitive chemoradiation, or Stage IV non-squamous non-small cell lung cancer. The disease must be measurable (RECIST 1.1). Performance status (ECOG) 0 or 1.
- Earlier treatment
- People who had earlier treatment with KRAS G12C inhibitors, FAK inhibitors or pan-RAS inhibitors cannot join.
- Biomarker or test result
- KRAS G12C mutation confirmed by a central laboratory.
Main reasons for not taking part
- Another known driver mutation with an approved first-line targeted therapy
- Brain or spinal cord spread (CNS metastases, leptomeningeal metastases, spinal cord compression) that is not yet controlled
- Earlier treatment with KRAS G12C inhibitors, FAK inhibitors or pan-RAS inhibitors
- Another cancer in the past 3 years, except cancers treated to remove all of the disease
- Uncontrolled heart or blood vessel disease, severe active infection, interstitial lung disease or autoimmune disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07833202, who can take part
Where in China
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaContact: Anwen LiuNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Jeyou Pharmaceutical Co., Ltd.
- Trial code
- NCT07833202
- Record updated
- 24 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Has another known driver mutation with approved first-line targeted therapy; Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors; 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; 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.