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Trial 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
NCT ID:
NCT05504278
Condition:
Advanced Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Cisplatin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
pemetrexed
Description:
500mg/m^2, Q3W, day1, i.v.
Arm group label:
IBI351 in combination with Sintilimab and pemetrexed
Arm group label:
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
Intervention type:
Drug
Intervention name:
cis-platinum
Description:
75mg/m^2, Q3W, day1, i.v.
Arm group label:
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200mg, Q3W, day1, i.v.
Arm group label:
IBI351 in combination with Sintilimab
Arm group label:
IBI351 in combination with Sintilimab and pemetrexed
Arm group label:
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
Other name:
IBI308
Intervention type:
Drug
Intervention name:
IBI351
Description:
recommended dose, po
Arm group label:
IBI351 in combination with Sintilimab
Arm group label:
IBI351 in combination with Sintilimab and pemetrexed
Arm group label:
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
Arm group label:
IBI351 monotherapy
Other name:
GFH925
Intervention type:
Drug
Intervention name:
carboplatin
Description:
AUC=5, Q3W, day1, i.v.
Arm group label:
IBI351 in combination with Sintilimab pemetrexed and cis-platinum/carboplatin
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
2. Unresectable or metastatic disease
3. Adequate organ function
Exclusion Criteria:
1. History of intestinal disease or major gastric surgery or inability to swallow oral
medications
2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
3. Active brain metastases.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin Province Cancer Hospital
Address:
City:
Jilin
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng
Phone:
0431-80596315
Email:
jl.cheng@163.com
Start date:
September 20, 2022
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504278
