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

Running, not enrolling · Phase 2

Conditions studied: Metastatic Lung Adenocarcinoma, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

In brief

This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

Key facts

Study ID: NCT04533451
Run by: Alliance for Clinical Trials in Oncology
People needed: 101
Starts: 2020-11-16
Expected to finish: 2027-05-31
Last updated by the study team: 2025-06-13

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
Alaska Women's Cancer Care — Anchorage, Alaska, United States
Anchorage Oncology Centre — Anchorage, Alaska, United States
Katmai Oncology Group — Anchorage, Alaska, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States
Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
Kingman Regional Medical Center — Kingman, Arizona, United States
Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
PCR Oncology — Arroyo Grande, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States
Mission Hope Medical Oncology - Santa Maria — Santa Maria, California, United States
Saint Helena Hospital — St. Helena, California, United States
Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
The Medical Center of Aurora — Aurora, Colorado, United States
Boulder Community Foothills Hospital — Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado, United States
Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
National Jewish Health-Main Campus — Denver, Colorado, United States
The Women's Imaging Center — Denver, Colorado, United States
Porter Adventist Hospital — Denver, Colorado, United States
Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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