Jilin Province Cancer Hospital
Jilin City, Changchun, China
Location status: Recruiting
Recruiting
NCT Number: NCT05504278
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy. There will be five cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Those five cohorts (A, B,C ,D and E) are treated with IBI351, IBI351+Sintilimab,IBI351+pemetrexed+cis-platinum/carboplatin,IBI351+Cetuximab, or IBI351+pemetrexed+cis-platinum/carboplatin respectively.
IBI351 is an orally available small molecule inhibitor of KRAS G12C.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
IBI351
Drugrecommended dose, po
Other names: GFH925
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.
Other names: IBI308
Cis-platinum
Drug75mg/m^2, Q3W, day1, i.v.
Primary outcomes
-
Number of participants with dose limiting toxicity
Time frame: 12 months
Number of participants with dose limiting toxicity in the dose escalation period
-
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents
Time frame: 24 months
Objective response rate per RECIST v1.1
-
Safety indicators during the introduction phase for IBI351 combination treatment :
Time frame: 24 months
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
Secondary outcomes
-
Evaluate plasma peak concentration of IBI351
Time frame: 12 months
Cmax
-
Evaluate area under the plasma concentration-time curve (AUC) of IBI351
Time frame: 12 months
AUC
-
Evaluate terminal half-life (t1/2) of IBI351
Time frame: 12 months
t1/2
-
Evaluate clearance of IBI351 from the plasma
Time frame: 12 months
CL/F
-
Evaluate distribution of IBI351
Time frame: 12 months
V/F
-
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index
Time frame: 24 months
PFS, DCR,DOR, TTR per RECIST v1.1; OS
-
Number of subjects with adverse events of interest
Time frame: 24 months
AE
-
Number of subjects with treatment-related adverse events
Time frame: 24 months
TRAE
-
Number of subjects with serious adverse events
Time frame: 24 months
SAE
-
Number of subjects with treatment-emergent adverse events
Time frame: 24 months
TEAE
-
Overall Survival
Time frame: 24 months
OS
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Industry
Registry information
Official study title
An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2027
- First posted
- Aug 17, 2022
- Registry last updated
- Jan 27, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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