nct04533451

Eligibility

Inclusion Criterea

• Documentation of Disease: 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 flat dose every 42 days * MK-3475 (pembrolizumab) 200 mg IV / 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 are post-organ transplantation, or are receiving ongoing immunosuppression treatment. Patients will be ineligible if they have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) * Note: Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients who require inhaled corticosteroids would not be excluded from the study. Patients with vitiligo or resolved childhood asthma/atopy would not be excluded from the study. Patients who require local steroid injections (for example, a steroid injection to a joint) would not be excluded from the study
• 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 oral and IV corticosteroids for this condition and asymptomatic at registration
• Age >= 70 years of age
• Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
• Platelet count: >= 100,000/mm^3 (100 x 10^9/L)
• Calculated creatinine clearance >= 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 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)
• Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures

Exclusion Criterea