Actively Recruiting
The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study
Led by Guangdong Association of Clinical Trials · Updated on 2026-03-11
48
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
G
Guangdong Association of Clinical Trials
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of IBI351 and cetuximab β for treating adults with untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) that has the KRAS G12C mutation. This Phase II, single-arm, multicenter study seeks to assess the safety and effectiveness of this treatment in patients who have not received prior systemic therapy for this lung cancer subtype. The goal is to measure tumor response using established criteria and monitor patient survival and disease progression. Participants will receive oral IBI351 at a dose of 600 mg twice daily, combined with an intravenous infusion of cetuximab β at 500 mg/m² every two weeks. Each treatment cycle is two weeks long, and therapy continues until the cancer worsens or unacceptable side effects occur. Dosage adjustments may be made based on patient tolerance. This study does not include a comparison group and follows patients through their treatment course. Throughout the study, patients will undergo regular assessments including tumor measurements using RECIST version 1.1 criteria, safety evaluations, and monitoring of disease control and survival outcomes for up to two years. Researchers will track objective response rate as the primary outcome, along with secondary outcomes like progression-free survival, time to response, overall survival, and adverse events. Participation involves ongoing clinical evaluations and laboratory testing to ensure safety and measure treatment impact.
CONDITIONS
Brief Title
IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent.
- Male or female aged 18 to 75 years.
- Life expectancy of at least 3 months.
- Confirmed locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer not suitable for curative chemoradiotherapy.
- Documented KRAS G12C mutation from a certified lab.
- ECOG performance status score of 0 or 1.
- No prior systemic anti-tumor therapy for advanced non-squamous NSCLC; prior adjuvant therapy allowed if recurrence occurred 6 months or more after last treatment.
- At least one measurable lesion per RECIST 1.1 criteria.
- Adequate organ and bone marrow function as defined by specific blood count and liver, kidney, coagulation, and magnesium levels.
- Residual toxicities from prior therapy resolved to baseline or Grade 1.
- Controlled immune-related endocrine adverse events allowed if stable.
- Use of effective contraception during and 6 months after study treatment; negative pregnancy test for females of childbearing potential before treatment.
You will not qualify if you...
- NSCLC with mixed small cell or predominantly squamous cell carcinoma components.
- Presence of EGFR sensitizing mutation, ALK rearrangement, ROS-1 fusion, or other approved genomic alterations.
- Significant cardiovascular or cerebrovascular disease within defined recent timeframes.
- Active central nervous system metastases; treated brain metastases allowed if stable and asymptomatic.
- Significant interstitial lung disease, radiation pneumonitis, or other severe pulmonary conditions.
- Gastrointestinal disorders affecting drug absorption or swallowing.
- Major active or chronic infections including HIV, active hepatitis B or C, and active tuberculosis.
- Symptomatic pleural, peritoneal, or pericardial effusions requiring repeated drainage.
- Poorly controlled systemic diseases such as hypertension or diabetes.
- History of other active cancers within 2 years except certain treated localized cancers.
- Prior treatment with KRAS G12C inhibitors or cetuximab or analogues.
- Recent use of certain anti-tumor therapies, Chinese herbal medicines, immunomodulatory drugs, or radiotherapy within specified timeframes.
- Major surgery within 28 days before study.
- Use of certain medications affecting drug metabolism unless approved.
- Participation in another interventional clinical trial.
- Use of immunosuppressive drugs or live attenuated vaccines within specified timeframes.
- Known or suspected autoimmune disease or primary immunodeficiency.
- History of organ transplantation.
- Recent severe thromboembolic events.
- Known allergy to study drugs.
- Pregnant or breastfeeding women.
- Any other condition making participation unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria
Participants receive oral IBI351 twice daily combined with intravenous cetuximab β every two weeks. Treatment cycles repeat every two weeks and continue until disease progression, unacceptable toxicity, or other protocol criteria for discontinuation.
Biweekly visits for intravenous cetuximab β infusion
Trial Site Locations
Total: 7 locations
1
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
3
The First People's Hospital of Foshan
Foshan, China
Actively Recruiting
4
The first affiliated hospital of nanchang university
Nanchang, China
Actively Recruiting
5
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
6
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, China
Not Yet Recruiting
7
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Not Yet Recruiting
Research Team
Q
Qing Zhou, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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