This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.
Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
Unresectable or metastatic disease
Adequate organ function
Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.
History of intestinal disease or major gastric surgery or inability to swallow oral medications
Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
Active brain metastases.
Parallel
IBI351
Drugrecommended dose, po
Cetuximab
Drug500mg/m\^2, Q2W, day1, i.v.
pemetrexed
Drug500mg/m\^2, Q3W, day1, i.v.
Carboplatin
DrugAUC=5, Q3W, day1, i.v.
Sintilimab
Drug200mg, Q3W, day1, i.v.
cis-platinum
Drug75mg/m\^2, Q3W, day1, i.v.
Number of participants with dose limiting toxicity
Number of participants with dose limiting toxicity in the dose escalation period
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents
Objective response rate per RECIST v1.1
Safety indicators during the introduction phase for IBI351 combination treatment :
Number of participants with Adverse events (AE), Treatment Emergent Adverse events (TEAE), treatment-related Adverse events (TEAE), TRAE) and the incidence of Serious Adverse events (SAE) (CTCAE v5.0 standard), with abnormal vital signs, abnormal physical exams, abnormal laboratory results and abnormal 12-lead electrocardiogram
Evaluate plasma peak concentration of IBI351
Cmax
Evaluate area under the plasma concentration-time curve (AUC) of IBI351
AUC
Evaluate terminal half-life (t1/2) of IBI351
t1/2
Evaluate clearance of IBI351 from the plasma
CL/F
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