Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC)
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Keep this study
Lead
Formycon AG
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
Confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated (ie, documentation of absence of tumor-activating/sensitizing EGFR mutations AND absence of ALK gene rearrangements).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You may not be if
Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
Known one of the mutations listed below:
* ROS1 fusion gene
* BRAF-V600E
* RET fusion
* MET Exon 14
Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and are also off steroids 3 days prior to dosing with trial treatment. Stable brain metastases by this definition should be established prior to the first dose of trial treatment. Patients with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion \>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
Prior treatment with any anti-programmed cell death 1, PD-L1, or programmed cell death ligand 2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against indoleamine 2, 3-dioxygenase, PD-L1, interleukin 2 receptor, or glucocorticoid-induced tumor necrosis factor receptor-related protein.
Clareo Health | Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC)
