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