Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

Trial details

Who runs it

Akeso

Trial code

NCT05636267

Record updated

2026. március 9.

Original description

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.Read full original descriptionShow less

A Multicenter, Open-Label, Phase Ib/II Study of AK119 and AK112 With or Without Chemotherapy in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.

Inclusion: Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure; Age ≥ 18 and ≤ 75, male or female; Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer; EGFR activating mutation confirmed by tumor histology, cytology or hematology; Failed to previous EGFR-TKI treatment; ECOG performance status 0 to1; Life expectancy ≥3 months; At least one measurable lesion according to RECIST v1.1; Adequate organ function.

Exclusion: The toxicity of previous anti-tumor therapy has not been alleviated; Any other conditions that, in the opinion of the investigator, may increase the risk when receiving the investigational product; Have suffered from the second primary active malignant tumor in the past 3 years; Active autoimmune diseases in the past 2 years; History of interstitial lung disease or noninfectious pneumonitis; Suffering from clinically significant cardiovascular or cerebrovascular diseases; History of severe bleeding tendency or coagulation dysfunction; History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months; Serious infection in the past 4 weeks; Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks; History of human immunodeficiency virus (HIV) infection; History of severe hypersensitivity reactions to other mAbs; History of organ transplantation; Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks; Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma; There are other driving gene mutations that can obtain effective treatment; Symptomatic central nervous system metastases; Uncontrolled massive ascites, pleural effusion or pericardial effusion.

ClinicalTrials.gov NCT05636267