Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer

Overview

About this study

The purpose of this study is to estimate the adverse event profile of MK-3475 (pembrolizumab) over the first six months of treatment, in non-small cell lung cancer patients who are 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

La Crosse, Wis.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20519861

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