Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer

Inclusion Criteria

• •1. Has a pathologically proven recurrent or metastatic non squamous non small cell lung cancer
• •2. (a) Previously received at least one line of prior systemic therapy for metastatic disease.
• •i. If the patient has a sensitizing EGFR mutation or ALK rearrangement, the patient must have received at least one prior targeted therapy for metastatic disease (ie, EGFR TKI therapy or ALK TKI therapy, respectively).
• •ii. There is no limit on prior therapies allowed. Patients must have completed previous treatment (including other investigational therapy) in greater than or equal to the following times prior to initiation of trial treatment:
• •1. Anti cancer monoclonal antibody (mAb) therapy must be completed ≥ 3 weeks prior to trial treatment
• •2. Chemotherapy administered in a daily or weekly schedule must be completed ≥ 1 week prior to trial treatment
• •3. Chemotherapy administered in an every 2 week schedule must be completed ≥ 2 weeks prior to trial treatment
• •4. Chemotherapy administered in an every 3 week schedule must be completed ≥ 3 weeks prior to trial treatment
• •5. Targeted small molecule therapy must be completed ≥ 1 week prior to trial treatment OR (b) Have not received prior systemic therapy for their cancer in recurrent or metastatic setting, AND have a tumor with Tumor Proportion Score (TPS) ≥ 50% as measured by 22C3 PD L1 IHC test, AND no evidence of a sensitizing EGFR mutation or ALK rearrangement.
• •3. Prior radiation therapy allowed as long as completed in the following times prior to initiation of trial treatment:
• •1. Definitive curative intent radiation ≥ 3 weeks prior to trial treatment
• •2. Palliative body radiation ≥ 1 week prior to trial treatment
• •3. Stereotactic brain radiation ≥ 1 week prior to trial treatment
• •4. Whole brain radiation ≥ 2 weeks prior to trial treatment
• •4. Patients with previously treated (with radiation or surgery) brain metastases that are stable are allowed. Patients with stable or progressing metastases must have metastases ≤ 1.5 cm, be asymptomatic, and either not be on steroids or be on 10 mg prednisone equivalent or less.
• •5. Has measurable disease based on RECIST v1.1 criteria
• •6. Is medically able and willing to undergo needle biopsy of a tumor lesion. PD L1 expression is not required to enroll in the trial.
• •7. Has life expectancy ≥ 3 months
• •8. Ability to understand and the willingness to sign a written informed consent document.
• •9. ≥ 18 years of age on day of signing informed consent
• •10. ECOG performance status of 0 or 1 (Appendix A)
• •11. Adequate organ function:
• •1. Absolute neutrophil count (ANC) ≥ 1,000/mcL
• •2. Platelets ≥ 75,000/mcL
• •3. Hemoglobin ≥ 8 g/dL
• •4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 50 mL/min for patient with creatinine levels \> 1.5 x institutional ULN
• •5. Serum total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN
• •6. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN OR ≤ 5 x ULN for patients with liver metastases
• •12. Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to the first dose of trial treatment. They must also agree to two barrier methods or a barrier method plus a hormonal method, or agree to abstain from heterosexual activity, for the course of the study through 120 days after the last dose of trial treatment. Females who have been surgically sterilized or are free from menses for \> 1 year (postmenopausal) may enroll.
• •13. Male patients with a female partner of childbearing potential should agree to use a barrier method of contraception, or agree to abstain from heterosexual activity for the course of the study through 120 days after the last dose of trial treatment.