Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
A Biomarker Study of Low-Dose IL-2 Plus Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 weeks, 6 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "OUTLINE: Patients will be treated with pembrolizumab 200 mg IV once every 3 weeks in combination with IL-2 given at 5 million IU subcutaneously twice daily for 3 weeks (5 days on, 2 days off each week, first dose in clinic and subsequent doses at home)."
- "After completion of the study treatment, patients are followed for up for 6 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early phase 1 study tests low-dose interleukin-2 (IL-2) with pembrolizumab in adults with stage IV non-small cell lung cancer that has not been treated for advanced disease. Stage IV means the cancer has spread to distant parts of the body. Researchers will study how the drugs affect immune cells called T cells and how well the treatment works.
This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with stage IV non-small cell lung cancer that can be measured on scans.
- Have had no treatment for advanced lung cancer.
- If cancer has spread to the brain, have no symptoms, or have had treatment with the cancer now stable.
- Be able to care for yourself and be up and about at least half of your waking hours, with an expected lifespan longer than 12 weeks.
- Have blood counts and liver and kidney test results that meet the study’s limits.
- Have a tumor PD-L1 test result of at least 1%, or a result that could not be determined. PD-L1 is a protein linked to immune responses.
- If you or your partner could become pregnant, agree to avoid sex that could cause pregnancy or use highly effective birth control during treatment and for at least 5 months after the last dose.
- Be able to understand and sign the consent form. If you could become pregnant, have a negative blood pregnancy test within 14 days before treatment.
Who can't join
- Prior chemotherapy or immune treatment for advanced lung cancer; prior drugs targeting PD-1 or PD-L1; a cancer gene change that can be treated with a targeted drug; or a known PD-L1 result of 0%.
- A past organ transplant or bone marrow transplant from a donor, or major surgery within 28 days before treatment.
- Severe organ problems from fast-growing cancer, or another active cancer that needs treatment.
- Medicines that weaken the immune system within 2 weeks before treatment, with some exceptions for brief low-dose use and certain steroids. A history or risk of immune disease that attacks the body also excludes people, with exceptions for stable thyroid disease, controlled type 1 diabetes, and certain limited, controlled skin conditions.
- A history of certain lung scarring or inflammation, active lung inflammation on a scan, a heart rhythm test result called QTc above 470 milliseconds, or significant liver disease.
- Known HIV, active tuberculosis, a severe infection within 4 weeks before treatment, or a live flu vaccine within 4 weeks before treatment or during the study.
- An experimental drug within 4 weeks before treatment, or longer if the drug stays in the body longer; or a past severe allergic reaction to certain antibody or fusion-protein medicines.
- Being pregnant, breastfeeding, or planning to become pregnant during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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. This includes adenocarcinoma and squamous cell carcinoma. 2. Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 3. No prior therapy for advanced NSCLC. 4. Patients with brain metastasis are eligible if they are asymptomatic or treated and stable. 5. Age greater than or equal to 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 7. Life expectancy of greater than 12 weeks. 8. Patients must have adequate organ and marrow function, including: 1. Absolute neutrophil count (ANC) ≥ 1,500/mcL 2. Platelet count ≥ 100,000/mcL 3. Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this) 4. 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) 5. Serum bilirubin l≤ 1.5 x ULN 6. Creatinine Clearance \> 60 mL/min 9. Patients must have tumor PD-L1 expression of ≥1% (by 22c3 PD-L1 companion testing); patients whose PD-L1 status could not be determined are also eligible. Patients with known PD-L1 of 0% will be excluded. 10. For women of childbearing potential or men with sexual partners 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. 1. 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). 2. 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 postovulation methods) and withdrawal are not acceptable methods of contraception. 11. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 12. Any prior chemotherapy or immunotherapy for advanced lung cancer. 13. Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents. 14. Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc). 15. Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation. 16. Major surgical procedure within 28 days prior to cycle 1, day 1. 17. Evidence of visceral crisis (severe organ dysfunction as assessed by signs, symptoms, and laboratory values, resulting from rapid progression of neoplastic disease). 18. Active concomitant malignancy that requires therapy. 19. Treatment with systemic immunosuppressive medications (e.g., prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1. 1. Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or premedication for contrast dye allergy) are eligible. 2. The use of inhaled corticosteroids for chronic obstructive pulmonary disease (COPD) and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. 20. History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis 1. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible. 2. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible. 3. Patients with eczema, psoriasis, or lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible provided they meet the following conditions: * Rash must cover \< 10% of body surface area (BSA) * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) * No acute exacerbations of underlying condition within the last 12 months (requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids) 21. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. 22. QTc of \>470 msec by EKG. 23. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease. 24. Known HIV infection. 25. Active tuberculosis. 26. Administration of a live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks before Cycle 1, Day 1 or at any time during the study. 27. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 28. Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer). 29. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 30. Patients who are pregnant or lactating, or who are intending to become pregnant during the study. 1. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
Study sites (1)
GA
- Emory University/Winship Cancer Institute · Atlanta, GA 30322Mashunté Holmes, PhD · Study contact · 404-778-1972 · mashunte.holmes@emory.eduSuresh S. Ramalingam · Principal investigatorMore trials in Atlanta