Lung Cancer Clinical Trial

Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Untreated stage II-III 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
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
Active or history of autoimmune disease or immune deficiency
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
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
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
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 allogeneic stem cell or solid organ transplantation
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT04991025

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities
Basking Ridge New Jersey, 07920, United States More Info
Paul Paik, MD
Contact
646-608-3759
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown New Jersey, 07748, United States More Info
Paul Paik, MD
Contact
646-608-3759
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale New Jersey, 07645, United States More Info
Paul Paik, MD
Contact
646-608-3759
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack New York, 11725, United States More Info
Paul Paik, MD
Contact
646-608-3759
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison New York, 10604, United States More Info
Paul Paik, MD
Contact
646-608-3759
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States More Info
Paul Paik, MD
Contact
646-608-3759
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale New York, 11553, United States More Info
Paul Paik, MD
Contact
646-608-3759

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT04991025

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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