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 (May 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
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)
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.
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