Clinical trial NCT05504278: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Non-Small Cell Lung Cancer
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
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:

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.

Primary outcomes:
measure: Number of participants with dose limiting toxicity
timeFrame: 12 months
measure: Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents
timeFrame: 24 months
measure: Safety indicators during the introduction phase for IBI351 combination treatment :
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate plasma peak concentration of IBI351
timeFrame: 12 months
measure: Evaluate area under the plasma concentration-time curve (AUC) of IBI351
timeFrame: 12 months
measure: Evaluate terminal half-life (t1/2) of IBI351
timeFrame: 12 months
measure: Evaluate clearance of IBI351 from the plasma
timeFrame: 12 months
measure: Evaluate distribution of IBI351
timeFrame: 12 months
measure: Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index
timeFrame: 24 months
measure: Number of subjects with adverse events of interest
timeFrame: 24 months
measure: Number of subjects with treatment-related adverse events
timeFrame: 24 months
measure: Number of subjects with serious adverse events
timeFrame: 24 months
measure: Number of subjects with treatment-emergent adverse events
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Jilin
country: China
facility: Jilin Province Cancer Hospital
state: Changchun
Study officials:
References: