Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
18 Years and older, Male and Female
WINSHIP5477-21 (primary)
NCI-2022-00931
STUDY00003612
Summary
This early phase I trial investigates whether low-dose interleukin-2 (IL-2) and pembrolizumab works in treating patients with stage IV non-small cell lung cancer. 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. IL-2 works in the body to help create more T-cells and strengthens the immune system. Giving IL-2 and pembrolizumab may improve the response of the immune system against cancer and result in better outcomes in patients with stage IV non-small cell lung cancer.
Objectives
PRIMARY OBJECTIVE:
I. Measuring the phenotypic, transcriptional, and epigenetic profiles of PD-1+ CD8 T cells as well as tumor response in patients with stage IV non-small cell lung cancer (NSCLC) treated with the combination of aldesleukin (IL-2) and pembrolizumab.
SECONDARY OBJECTIVE:
I. Assessment of the safety profile, response rate, and overall survival.
OUTLINE:
Patients receive aldesleukin subcutaneously (SC) twice daily (BID) on days 1-5, 8-12, and 15-19 of cycle 1. Patients also receive pembrolizumab intravenously (IV) on day 1. Cycles repeat every 3 or 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study.
After completion of the study treatment, patients are followed for up for 6 weeks.
Eligibility
- Patients must have Stage IV non-small cell lung cancer (NSCLC), based on the 8th edition of the American Joint Committee on Cancer (AJCC) NSCLC Staging System
- Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- No prior therapy for advanced NSCLC
- Patients with brain metastasis are eligible if they are asymptomatic or treated and stable
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of greater than 12 weeks
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelet count >=100,000/mcL
- Hemoglobin >= 9.0 g/dL (patients may be transfused to meet this)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
- Serum bilirubin =< 1.5 x ULN
- Serum creatinine < 3.0 mg/dL
- Patients must have tumor PD-L1 expression of >= 1% (by immunohistochemistry); patients whose PD-L1 status could not be determined are also eligible
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment
* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
* Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Ability to understand and the willingness to sign a written informed consent document
Treatment Sites in Georgia
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