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New treatment option for Lung Cancer (Non-Small Cell)
Official title IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
ClinicalTrials.gov ID: NCT07198841
What this study is testing
What is IBI351 combined with cetuximab β?
IBI351 combined with cetuximab β is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lung cancer (non-small cell).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study Design: a Phase II, single-arm, multicenter, prospective, interventional study. Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily participate in the study and sign the informed consent form (ICF).
- Male or female people aged ≥18 years and ≤75 years at the time of signing the ICF.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung...
- Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.
You likely can't join if
- Histologically or cytologically confirmed NSCLC with mixed small cell components or predominantly squamous cell carcinoma components.
- Presence of EGFR sensitizing mutation, ALK rearrangement, ROS-1 fusion, or other genomic alterations for which NMPA-approved first-line NSCLC...
- Significant cardiovascular or cerebrovascular disease, including: 1）Clinically significant cardiovascular events within 6 months (e.g., myocardial...
- Active infection requiring systemic therapy.
- Baseline positive HIV antibody (HIV-Ab); acute or chronic active hepatitis B (defined as HBsAg and/or HBcAb positive AND HBV-DNA \> 2500 copies/mL or...
- Active pulmonary tuberculosis. 8. Symptomatic pleural, peritoneal, or pericardial effusions requiring repeated drainage. 9\. Poorly controlled...
See the full eligibility criteria
- Voluntarily participate in the study and sign the informed consent form (ICF).
- Male or female people aged ≥18 years and ≤75 years at the time of signing the ICF.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC), per the International Association for the Study of Lung...
- Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- No prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC. people who received prior adjuvant therapy are eligible provided disease recurrence occurred ≥6 months after the last dose of...
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions within a prior radiation field or after local therapy can be considered target lesions if documented...
- Adequate organ and bone marrow function, defined as: 1）Hematopoietic: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL. No transfusion or treatment with granulocyte...
- Histologically or cytologically confirmed NSCLC with mixed small cell components or predominantly squamous cell carcinoma components.
- Presence of EGFR sensitizing mutation, ALK rearrangement, ROS-1 fusion, or other genomic alterations for which NMPA-approved first-line NSCLC therapies exist.
- Significant cardiovascular or cerebrovascular disease, including: 1）Clinically significant cardiovascular events within 6 months (e.g., myocardial infarction, angina, heart failure, severe arrhythmia) or history of...
- Active infection requiring systemic therapy.
- Baseline positive HIV antibody (HIV-Ab); acute or chronic active hepatitis B (defined as HBsAg and/or HBcAb positive AND HBV-DNA \> 2500 copies/mL or 500 IU/mL); or acute or chronic active hepatitis C (HCV antibody...
- Active pulmonary tuberculosis. 8. Symptomatic pleural, peritoneal, or pericardial effusions requiring repeated drainage. 9\. Poorly controlled systemic diseases despite standard therapy (e.g., hypertension: systolic BP...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Beijing, China
- Foshan, China
- Nanchang, China
- Nanning, China
- Shijiazhuang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Beijing, China; Foshan, China; Nanchang, China; Nanning, China; Shijiazhuang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.