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

Exclusion criteria

• Prior treatment with albumin-bound paclitaxel or gemcitabine
• Prior systemic anticancer therapy for advanced squamous cell lung cancer
• Untreated brain metastasis. Patients with treated brain metastases who are off steroids are eligible
• Peripheral neuropathy greater than grade 1
• Malignancies within the past 5 years other than non-melanoma skin cancer or insitu cervical cancer status post treatment
• Patients with other serious medical illnesses including, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
• Class III or IV congestive heart failure by New York Heart Association