Clinical Trials

Inclusion Criteria:

• Histologic or cytologic diagnosis of non-small cell lung  cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation.
• Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules:  
  • MK-3475 (pembrolizumab) 200 mg IV flat dose every 21 days or 400 mg IV every 42 days;
  • MK-3475 (pembrolizumab) 200 mg IV or 400 mg IV + carboplatin area under the curve (AUC) = 5 + pemetrexed 500 mg/m^2 (20% chemotherapy dose reduction is permitted per the discretion of the treating physician).
• Patients will be ineligible if they have an autoimmune disorder, are post-organ  transplantation, or are receiving ongoing immunosuppression treatment.
• Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration.
• No planned radiation or other cancer treatment in the 3 months following registration . 
• No untreated brain metastases. Patients must be off corticosteroids and asymptomatic at registration.
• Absolute neutrophil count (ANC) ≥ 1500/mm^3 (1.5 x 10^9/L).
• Platelet count: ≥ 100,000/mm^3 (100 x 10^9/L).
• Creatinine ≥ 30 mL/min* for patients enrolled to pembrolizumab alone and > 45 mL/min for patients enrolled to chemotherapy + pembrolizumab.
  • * Calculated using the Cockcroft-Gault formula.  
• Total serum bilirubin ≤ 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's  disease).
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3 x ULN (≤  5.0 x ULN if liver metastases present).
• Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if bone or liver metastases present).
• Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures.

Exclusion Criteria:

• None.

Eligibility last updated 8/27/21. Questions regarding updates should be directed to the study team contact.