Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04533451
Eligibility Criteria:
Inclusion Criteria:
* 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 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) Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT04533451
Study Brief:
Protocol Section:
NCT04533451