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)

Inclusion Criteria:

• Histologically confirmed or cytologically confirmed diagnosis of Stage IVnon-squamous NSCLC.

• Confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphomakinase (ALK)-directed therapy is not indicated (ie, documentation of absence oftumor-activating/sensitizing EGFR mutations AND absence of ALK gene rearrangements).

• No prior systemic treatment for metastatic non-squamous NSCLC. Patients who receivedadjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy wascompleted at least 12 months prior to the development of metastatic disease.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

• Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous cell tumorsand 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 areclinically stable for at least 2 weeks and have no evidence of new or enlargingbrain metastases and are also off steroids 3 days prior to dosing with trialtreatment. Stable brain metastases by this definition should be established prior tothe first dose of trial treatment. Patients with known untreated, asymptomatic brainmetastases (ie, no neurological symptoms, no requirements for corticosteroids, no orminimal surrounding edema, and no lesion >1.5 cm) may participate but will requireregular imaging of the brain as a site of disease.

• Prior treatment with any anti-programmed cell death 1, PD-L1, or programmed celldeath ligand 2 agent or an antibody targeting other immuno-regulatory receptors ormechanisms. Examples of such antibodies include (but are not limited to) antibodiesagainst indoleamine 2, 3-dioxygenase, PD-L1, interleukin 2 receptor, orglucocorticoid-induced tumor necrosis factor receptor-related protein.