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Recruiting NCT05504278

Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

Phase I Interventional Advanced Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI351, Cetuximab, pemetrexed, Carboplatin.
Who it may be relevant to
Registry conditions: Advanced Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug IBI351
    recommended dose, po
  • Drug Cetuximab
    500mg/m\^2, Q2W, day1, i.v.
  • Drug pemetrexed
    500mg/m\^2, Q3W, day1, i.v.
  • Drug Carboplatin
    AUC=5, Q3W, day1, i.v.
  • Drug Sintilimab
    200mg, Q3W, day1, i.v.
  • Drug cis-platinum
    75mg/m\^2, Q3W, day1, i.v.

Primary outcome measures

  • Number of participants with dose limiting toxicity [Time frame: 12 months]
  • Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents [Time frame: 24 months]
  • Safety indicators during the introduction phase for IBI351 combination treatment : [Time frame: 24 months]
Secondary outcome measures (11)
  • Evaluate plasma peak concentration of IBI351 [Time frame: 12 months]
  • Evaluate area under the plasma concentration-time curve (AUC) of IBI351 [Time frame: 12 months]
  • Evaluate terminal half-life (t1/2) of IBI351 [Time frame: 12 months]
  • Evaluate clearance of IBI351 from the plasma [Time frame: 12 months]
  • Evaluate distribution of IBI351 [Time frame: 12 months]
  • Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index [Time frame: 24 months]
  • Number of subjects with adverse events of interest [Time frame: 24 months]
  • Number of subjects with treatment-related adverse events [Time frame: 24 months]
  • Number of subjects with serious adverse events [Time frame: 24 months]
  • Number of subjects with treatment-emergent adverse events [Time frame: 24 months]
  • Overall Survival [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Jilin Province Cancer Hospital — Jilin City

Identifiers

NCT: NCT05504278 · CIBI351A301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗