Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT04533451

PHASE2

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

This study evaluates the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back after a period of improvement (recurrent) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of 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.

Official title: Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

101

Start Date

2020-11-16

Completion Date

2027-05-31

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Metastatic Lung Adenocarcinoma Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Adenocarcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8

Interventions

DRUG

Pembrolizumab

Given IV

DRUG

Pemetrexed

Given IV

DRUG

Carboplatin

Given IV

OTHER

Comprehensive Geriatric Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

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 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

Locations (505)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

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