A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Mar 20, 2024
  • participants needed
    40
  • sponsor
    Akeso
Updated on 21 April 2022

Summary

Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody

Details
Condition Advanced Non-small Cell Lung Cancer
Treatment docetaxel, AK104
Clinical Study IdentifierNCT05215067
SponsorAkeso
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18 to 75 years old
Have a life expectancy of at least 3 months
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered
No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations
Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator
Has adequate organ function

Exclusion Criteria

Undergone major surgery within 30 days prior to the first dose of study treatment
Active central nervous system (CNS) metastases
History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs)
Active Hepatitis B or Hepatitis C
Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity
Has received treatment with docetaxel
History of severe bleeding tendency or coagulation disorder
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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