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

Status: closed to accrual

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.

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

PRIMARY OBJECTIVE:

I. 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:

I. 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.

EXPLORATORY OBJECTIVES:

I. To disaggregate the adverse events and identify potential causes of individual adverse events.

II. To describe patient fatigue level as measured with the Multidimensional Fatigue Symptom Inventory – Short Form (MFSI-SF); exercise level using the Godin Leisure Time Exercise Questionnaire (GLTE); and other symptoms and concerns using the LASA questionnaires.

III. To estimate time-to-treatment failure for single-agent MK-3475 (pembrolizumab) and MK-3475 (pembrolizumab) + chemotherapy in older patients.

CORRELATIVE SCIENCE OBJECTIVES:

I. To evaluate whether older patients who experience fatigue or other adverse effects would be correlated with a change of PD-L1 therapy-responsive T cell subset (i.e. CX3CR1+CD11ahighCD8+ T-cells) in their peripheral blood from baseline (prior to therapy) to post therapy.

II. To determine the extent to which MK-3475 (pembrolizumab) demonstrates time dependent decrease in clearance in older adult patients (aged >= 70 years) with non-small cell lung cancer being treated with pembrolizumab monotherapy or in combination with cytotoxic chemotherapy.

III. To determine the intrapatient and interpatient variability in clearance in older adult (>= 70 years) patients with non-small cell lung cancer receiving pembrolizumab monotherapy and when combined with cytotoxic chemotherapy.

IV. To preliminarily explore the correlation between pembrolizumab exposure (AUC) with observed immune related toxicities in this older adult (aged >= 70 years) patient population receiving pembrolizumab monotherapy and when combined with cytotoxic 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 of disease progression or unacceptable toxicity. 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.

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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

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