Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers

Inclusion Criteria

• •Histologically confirmed squamous cell lung cancer
• •Newly diagnosed untreated Stage IV and/or recurrent after adjuvant therapy with metastatic disease
• •Patients previously treated with immune checkpoint inhibitor therapy are eligible
• •Measurable disease as per RECIST 1.1
• •Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy.
• •Age ≥ 18 years
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• •Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception method during treatment and for three months after completing treatment
• •Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
• •\< Grade 2 pre-existing peripheral neuropathy (per CTCAE)
• •Marrow and organ function as follows:
• •ANC ≥ 1500 cells/mm3
• •Platelets \> 100,000 cells/mm3
• •Hemoglobin\>9g/dL
• •Creatinine clearance ≥ 40mL/min
• •Bilirubin ≤ 1.5 mg/dL
• •AST/ALT≤2.5 x upper limit of normal range (ULN),
• •alkaline phosphatase ≤ 2.5 X upper limit of normal, unless bone metastasis in present in the absence of liver metastasis