Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
- Summary
- 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.
- Short title
- Efficacy and Safety of IBI351 in Combination With 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 Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-07-31
- First posted
- 2022-08-17
- Registry last updated
- 2025-01-27
- Primary completion date
- 2025-05-31
- Start date
- 2022-09-20
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05504278
- ClinicalTrials.gov ID
- NCT05504278
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Number of participants with dose limiting toxicity
Timeframe: 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
Timeframe: 24 months
Objective response rate per RECIST v1.1
Safety indicators during the introduction phase for IBI351 combination treatment :
Timeframe: 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
Evaluate plasma peak concentration of IBI351
Timeframe: 12 months
Cmax
Evaluate area under the plasma concentration-time curve (AUC) of IBI351
Timeframe: 12 months
AUC
Evaluate terminal half-life (t1/2) of IBI351
Timeframe: 12 months
t1/2
Evaluate clearance of IBI351 from the plasma
Timeframe: 12 months
CL/F
Evaluate distribution of IBI351
Timeframe: 12 months
V/F
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index
Timeframe: 24 months
PFS, DCR,DOR, TTR per RECIST v1.1; OS
Number of subjects with adverse events of interest
Timeframe: 24 months
AE
Number of subjects with treatment-related adverse events
Timeframe: 24 months
TRAE
Number of subjects with serious adverse events
Timeframe: 24 months
SAE
Number of subjects with treatment-emergent adverse events
Timeframe: 24 months
TEAE
Overall Survival
Timeframe: 24 months
OS
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- Jilin Province Cancer HospitalJilin City, ChinaRecruiting
Related records
Drugs (5)
Lead sponsors (1)
Conditions (1)
- Non-small cell lung carcinoma Primary condition