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