Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
NCT ID: NCT05504278
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
144 participants
INTERVENTIONAL
2022-09-20
2027-07-31
Brief Summary
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Detailed Description
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IBI351 is an orally available small molecule inhibitor of KRAS G12C.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%)
IBI351
recommended dose, po
pemetrexed
500mg/m\^2, Q3W, day1, i.v.
Carboplatin
AUC=5, Q3W, day1, i.v.
cis-platinum
75mg/m\^2, Q3W, day1, i.v.
IBI351 in combination with Cetuximab
IBI351
recommended dose, po
Cetuximab
500mg/m\^2, Q2W, day1, i.v.
IBI351 monotherapy
IBI351
recommended dose, po
IBI351 in combination with Sintilimab
IBI351
recommended dose, po
Sintilimab
200mg, Q3W, day1, i.v.
IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)
IBI351
recommended dose, po
pemetrexed
500mg/m\^2, Q3W, day1, i.v.
Carboplatin
AUC=5, Q3W, day1, i.v.
cis-platinum
75mg/m\^2, Q3W, day1, i.v.
Interventions
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IBI351
recommended dose, po
Cetuximab
500mg/m\^2, Q2W, day1, i.v.
pemetrexed
500mg/m\^2, Q3W, day1, i.v.
Carboplatin
AUC=5, Q3W, day1, i.v.
Sintilimab
200mg, Q3W, day1, i.v.
cis-platinum
75mg/m\^2, Q3W, day1, i.v.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Unresectable or metastatic disease
3. Adequate organ function
4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.
Exclusion Criteria
2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
3. Active brain metastases.
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Jilin Province Cancer Hospital
Jilin, Changchun, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI351A301
Identifier Type: -
Identifier Source: org_study_id
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