KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer

  • End date
    Aug 30, 2023
  • participants needed
  • sponsor
    Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Updated on 26 January 2021


This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment.

Condition Squamous Non Small Cell Lung Cancer
Treatment KN046, KN046 placebo
Clinical Study IdentifierNCT04474119
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV squamous NSCLC
No known epidermal growth factor receptor (EGFR) mutations
Has measurable disease
Has not received prior systemic treatment for their advanced/metastatic NSCLC
Can provide tumor tissue
Has a life expectancy of at least 3 months
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
Has adequate organ function
If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment
If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment

Exclusion Criteria

Untreated active CNS metastasis or leptomeningeal metastasis
Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment
Has received other anti-tumor treatment, including traditional Chinese medicine which has approved anti-tumor indication within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment
Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment
Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment
Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids)
Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management
History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
Previous malignant disease
History of uncontrolled intercurrent illness
Prior therapy with any antibody/drug targeting T cell coregulatory proteins
Known severe hypersensitivity reactions to antibody drug
Is pregnant or breastfeeding
Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance
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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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