Is NCT04991025 recruiting in Uniondale, NY?

Yes, NCT04991025 is currently recruiting participants at its Uniondale, NY location. This lung cancer clinical trial is actively enrolling qualified participants.

How do I join the lung cancer clinical trial in Uniondale?

To join this clinical trial in Uniondale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Uniondale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Cancer Clinical Trial in Uniondale, NY

About This Lung Cancer Study in Uniondale

The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Untreated stage II-III (AJCC 8th edition) non-small cell lung cancers with operable and resectable disease determined by a thoracic surgeon

Histologic confirmation of disease at MSKCC

Age 18 years or older

Karnofsky Performance Status ≥ 70

Adequate bone marrow, liver and renal function, as specified below:

Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9 /L

Lymphocyte count ≥0.5 x10\^9/L (500/µL)

Hemoglobin ≥ 9 g/dL

Platelets ≥ 100 x 10\^9 /L

Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)

AST and ALT ≤ 2.5 x ULN

Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.

Serum albumin ≥25 g/L (2.5 g/dL)

For patients not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 x ULN

For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

Negative PPD test or interferon-gamma release assay (including but not limited to QuantiFERON-TB Gold)

For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment

Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 5 months thereafter

Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors 1.1

Ability to provide written, informed consent. Legally Authorized Representatives are permitted.

Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ³ 200/µL, and have an undetectable viral load

Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. Note: The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.

Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Exclusion Criteria

Presence of an FDA approved targeted therapy for patients with NSCLC harboring a genomic aberration for which an FDA-approved targeted therapy is indicated

Hypersensitivity to platinum agents

Prior use of TNF-α inhibitor

Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment Note: this exclusion criteria has the following excpetions:

Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.

Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.

Topical steroids

Active or history of autoimmune disease or immune deficiency

Active or history of autoimmune disease or immune deficiency including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, antiphospholipid antibody syndrome Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis. Note: This exclusion criteria has the following exceptions:

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

Rash must cover \< 10% of body surface area

Disease is well controlled at baseline and requires only low-potency topical corticosteroids

No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted

Baseline hearing deficit (CTCAE version 4.0 grade 2 or higher)

Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush

Active tuberculosis or untreated, latent tuberculosis Note: If a patient has signs, symptoms, or a history suggestive of active tuberculosis, evaluation by an infectious disease physician will be required and active tuberculosis ruled-out prior to enrollment.

Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, or cerebrovascular accident) within 3 months prior to initiation of study treatment, or unstable arrhythmia Note: Patients are ineligible if they have a history of myocardial infarction or

Unstable angina within the past 12 months

Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study

Acute or chronic Hepatitis B or C infection

Known HIV infection requiring antiretroviral medications and those with AIDS

Active herpes zoster infection

Current treatment with anti-viral therapy for HBV

Non-healed infected skin ulcers

Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5mmol/L, calcium \> 12mg/dL or corrected serum calcium \> ULN)

Prior history of other malignancy with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer, localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast

Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia

Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.

Prior allogeneic stem cell or solid organ transplantation

Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications

Live, attenuated vaccines (e.g., FluMist) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with nivolumab, and for 5 months after the last dose of nivolumab.

Treatment with investigational therapy within 28 days prior to initiation of study treatment

Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment

History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

Known hypersensitivity to Chinese hamster ovary cell products or to any component of the nivolumab formulation

Known allergy or hypersensitivity to any component of the Certolizumab pegol formulation

Known allergy or hypersensitivity to any component of the platinum-based chemotherapy formulations

Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of nivolumab, within 3 months after the final dose of Certolizumab pegol, and within 6 months after the final dose of carboplatin, cisplatin, pemetrexed or gemcitabine treatment

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Uniondale?

Yes, this clinical trial (NCT04991025) has an active research site in Uniondale, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Cancer Treatment Options in Uniondale, NY

If you're searching for lung cancer treatment options in Uniondale, NY, this clinical trial (NCT04991025) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Uniondale research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung cancer clinical trials near you to find additional studies recruiting in your area.

Lung Cancer Clinical Trial in Uniondale, NY

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