This study is in progress, not accepting new patients

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

a study on Lung Cancer Non-Small Cell Lung Cancer Small Cell Carcinoma Lung Tumor

Summary

Eligibility
for people ages 70 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

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)

Details

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

  1. 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.

SECONDARY OBJECTIVES:

  1. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.

III. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy.

OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups.

GROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients complete questionnaires as well as undergo computed tomography (CT) scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study.

GROUP B: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity. Patients also receive pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles with pemetrexed and carboplatin repeat every 21 days in the absence. Additionally, patients complete questionnaires as well as undergo CT scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study.

After completion of study treatment, patients are followed up annually for up to 5 years after registration.

Keywords

Metastatic Lung Adenocarcinoma, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Adenocarcinoma of Lung, Non-Small-Cell Lung Carcinoma, Lung Neoplasms, pembrolizumab, Pemetrexed, Carboplatin, Geriatric Assessment, Comprehensive Geriatric Assessment, Quality-of-Life Assessment, pembrolizumab, pemetrexed, carboplatin

Eligibility

For people ages 70 years and up

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/m2 (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/mm3 (1.5 x 109/L)
  • Platelet count: >= 100,000/mm3 (100 x 109/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

  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Hope Cancer Care of Nevada-Pahrump
    Pahrump Nevada 89048 United States
  • Mission Hope Medical Oncology - Santa Maria
    Santa Maria California 93444 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT04533451
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 101 people participating
Last Updated