Back to resultsEfficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Primary Purpose
Advanced Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
pemetrexed
cis-platinum
Sintilimab
IBI351
carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
- Unresectable or metastatic disease
- Adequate organ function
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.
Sites / Locations
- Jilin Province Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
IBI351 in combination with Sintilimab and pemetrexed
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
IBI351 monotherapy
IBI351 in combination with Sintilimab
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Evaluate distribution of IBI351
V/F
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index
PFS, DCR,DOR, TTR per RECIST v1.1; OS
Number of subjects with adverse events of interest
AE
Number of subjects with treatment-related adverse events
TRAE
Number of subjects with serious adverse events
SAE
Number of subjects with treatment-emergent adverse events
TEAE
Full Information
NCT ID
NCT05504278
First Posted
August 11, 2022
Last Updated
May 25, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05504278
Brief Title
Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Official Title
An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
May 12, 2024 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with Sintilimab± chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.
Detailed Description
This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with Sintilimab± chemotherapy. There will be four cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Three cohorts (A, C and D) are treated with IBI351+Sintilimab, IBI351+Sintilimab+pemetrexed, or IBI351+Sintilimab+pemetrexed+cis-platinum/carboplatin, respectively, as first-line therapy. Cohort B enrolles subjects who is intolerant or has failed in standard-of care treatment,and is treated with IBI351+Cetuximab.
IBI351 is an orally available small molecule inhibitor of KRAS G12C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBI351 in combination with Sintilimab and pemetrexed
Arm Type
Experimental
Arm Title
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
Arm Type
Experimental
Arm Title
IBI351 monotherapy
Arm Type
Experimental
Arm Title
IBI351 in combination with Sintilimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
500mg/m^2, Q3W, day1, i.v.
Intervention Type
Drug
Intervention Name(s)
cis-platinum
Intervention Description
75mg/m^2, Q3W, day1, i.v.
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI308
Intervention Description
200mg, Q3W, day1, i.v.
Intervention Type
Drug
Intervention Name(s)
IBI351
Other Intervention Name(s)
GFH925
Intervention Description
recommended dose, po
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC=5, Q3W, day1, i.v.
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicity
Description
Number of participants with dose limiting toxicity in the dose escalation period
Time Frame
12 months
Title
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents
Description
Objective response rate per RECIST v1.1
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Evaluate plasma peak concentration of IBI351
Description
Cmax
Time Frame
12 months
Title
Evaluate area under the plasma concentration-time curve (AUC) of IBI351
Description
AUC
Time Frame
12 months
Title
Evaluate terminal half-life (t1/2) of IBI351
Description
t1/2
Time Frame
12 months
Title
Evaluate clearance of IBI351 from the plasma
Description
CL/F
Time Frame
12 months
Title
Evaluate distribution of IBI351
Description
V/F
Time Frame
12 months
Title
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index
Description
PFS, DCR,DOR, TTR per RECIST v1.1; OS
Time Frame
24 months
Title
Number of subjects with adverse events of interest
Description
AE
Time Frame
24 months
Title
Number of subjects with treatment-related adverse events
Description
TRAE
Time Frame
24 months
Title
Number of subjects with serious adverse events
Description
SAE
Time Frame
24 months
Title
Number of subjects with treatment-emergent adverse events
Description
TEAE
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
Unresectable or metastatic disease
Adequate organ function
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Sun
Phone
0512-69566088
Email
xiaodong.sun@innoventbio.com
Facility Information:
Facility Name
Jilin Province Cancer Hospital
City
Jilin
State/Province
Changchun
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Phone
0431-80596315
Email
jl.cheng@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
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