A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Eligibility Criteria

Inclusion Criteria: 1. Sign the Informed Consent Form (ICF) and be able to comply with the visit and related procedures as stipulated in the protocol. 2. Be male or female, aged ≥18 and ≤75 years old. 3. Have an expected survival time of ≥6 months. 4. Have histologically or cytologically confirmed locally advanced (IIIB/IIIC stage), metastatic or recurrent (IV stage) non-small cell lung cancer (NSCLC) that is not operable and not suitable for radical concurrent chemoradiotherapy, as classified by the 8th edition of the TNM staging system of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer. 5. All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation; and must have no sensitive mutations of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), or other gene mutation types approved by the National Medical Products Administration (NMPA) for first-line treatment of NS…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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