• Patients with stage IV NSCLC who had undergone no previous systemic therapy for stage IV disease.

• Patients with HIV must be on an effective combination anti-retroviral therapy (cART) regimen for ≥ 4 weeks. Also, patients need to meet the following criteria.

‣ Documented HIV viral load \< 400 copies/mL

⁃ No AIDS-defining opportunistic infections within the last 12 months

⁃ No concurrent incurable AIDS-defining malignancy

• Age \> 18 years at time of study entry.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Body weight \>30kg

• Adequate normal organ and marrow function as defined below:

‣ Hemoglobin ≥ 9.0 g/dL

⁃ Absolute neutrophil count (ANC) ≥ 1,000 per mm3

⁃ Platelet count ≥ 100,000 per mm3

⁃ CD4 T-cell count ≥ 100 per mm3 for HIV-infected patients

⁃ Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.

⁃ AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN

⁃ Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:

• Males: Creatinine CL (mL/min) = \[Weight (kg) x (140 - Age)\] / \[72 x serum creatinine (mg/dL)\] Females: Creatinine CL (mL/min) = \[Weight (kg) x (140 - Age) x 0.85\] / \[72 x serum creatinine (mg/dL)\]

• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

‣ Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).

⁃ Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

• Must have a life expectancy of at least 12 weeks.