A trial to show the similarity in effects, safety and immune response of FYB206 compared to Keytruda in people with metastatic non-squamous non-small cell lung cancer (NSCLC)

Prior treatment

• 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.

Other illness

• Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.

Other

• Known one of the mutations listed below: o ROS1 fusion gene o BRAF-V600E o RET fusion o MET Exon 14

• Histologically confirmed or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
• No prior systemic treatment for metastatic non-squamous NSCLC. Patients who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Confirmation that EGFR or ALK--directed therapy is not indicated (ie, documentation of absence of tumor--activating/sensitizing EGFR mutations AND absence of ALK gene rearrangements). Note if patient does not have documented genetic test results for EGFR and ALK available at the moment of ICF signature, it will be performed during screening locally.