Clinical Trial 21222

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04533451

Phase: Phase II
Principal Investigator: Al-Jumayli, Mohammed

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Overview

Study 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) A171901

Summary

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.

Objective

2.0 OBJECTIVES 2.1 Primary objective 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. 2.2 Secondary objectives 2.2.1 To disaggregate the adverse events and identify potential causes of individual adverse events. 2.2.2 To estimate overall survival. 2.2.3 To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire. 2.2.4 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.

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

Alimta (Pemetrexed); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); carboplatin ()

Inclusion Criteria

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 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)

Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to 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

Total serum bilirubin => Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) => Alkaline phosphatase => Other criteria may apply

Exclusion Criteria

Exclusion Criteria:

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

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

Other criteria may apply

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