OncoMatch/Clinical Trials/NCT07198841
IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Is NCT07198841 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies IBI351 combined with cetuximab β for lung cancer (non-small cell).
Treatment: IBI351 combined with cetuximab β — 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. Treatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity. Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and safety.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS G12C
Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.
Required: EGFR sensitizing mutation
Presence of EGFR sensitizing mutation... [excluded]
Required: ALK rearrangement
Presence of...ALK rearrangement... [excluded]
Required: ROS1 fusion
Presence of...ROS-1 fusion... [excluded]
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: KRAS inhibitor
Prior treatment with any KRAS G12C inhibitor.
Cannot have received: EGFR tyrosine kinase inhibitor
Presence of EGFR sensitizing mutation...for which NMPA-approved first-line NSCLC therapies exist.
Cannot have received: ALK inhibitor
Presence of...ALK rearrangement...for which NMPA-approved first-line NSCLC therapies exist.
Cannot have received: ROS1 inhibitor
Presence of...ROS-1 fusion...for which NMPA-approved first-line NSCLC therapies exist.
Cannot have received: cetuximab or its analogues
Prior treatment with cetuximab or its analogues.
Cannot have received: systemic anti-tumor therapy
Exception: Subjects who received prior adjuvant therapy are eligible provided disease recurrence occurred ≥6 months after the last dose of adjuvant therapy or the last session of radical radiotherapy.
No prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL. No transfusion or G-CSF, thrombopoietin, or erythropoietin within 14 days prior to hematology tests.
Kidney function
Serum creatinine ≤ 1.5 × ULN OR calculated creatinine clearance (CrCl) ≥ 60 mL/min (using Cockcroft-Gault formula) if Cr > 1.5 × ULN.
Liver function
Total bilirubin (TBIL) < 1.5 × ULN, AST and ALT < 2.5 × ULN; for Gilbert's syndrome, TBIL < 2 × ULN; for liver metastases, AST and ALT < 5.0 × ULN; if DBIL suggests extrahepatic obstruction, TBIL < 3.0 × ULN.
Adequate organ and bone marrow function, defined as: Hematopoietic: ANC ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL. No transfusion or treatment with G-CSF, thrombopoietin, or erythropoietin within 14 days prior to hematology tests. Hepatic: TBIL < 1.5 × ULN, AST and ALT < 2.5 × ULN. For Gilbert's syndrome, TBIL < 2 × ULN is acceptable. For subjects with liver metastases, AST and ALT < 5.0 × ULN is required. If DBIL suggests extrahepatic obstruction, TBIL < 3.0 × ULN is permitted. Renal: Serum creatinine ≤ 1.5 × ULN OR calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula) if Cr > 1.5 × ULN. Coagulation: PT/APTT < 1.5 × ULN and INR < 1.5 or within the therapeutic range for subjects on anticoagulation therapy. Magnesium: Serum magnesium within normal limits.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07198841 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS G12C is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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