Adding Certolizumab to Chemotherapy + Nivolumab for Operable Lung Cancer
This study is looking at people with Stage II or III lung cancer that can be treated with surgery. It's testing if adding a drug called certolizumab to standard chemotherapy (like cisplatin, pemetrexed, gemcitabine, or carboplatin) and nivolumab can help shrink the cancer more effectively. Researchers believe certolizumab might reduce inflammation caused by the cancer, making chemotherapy work better. The main goal is to see if this combination leads to a complete pathologic response (meaning no cancer cells are found after treatment) within two years. You might be able to join if you have untreated, operable non-small cell lung cancer and meet certain health requirements. The study aims to enroll 60 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 60 participants with Stage II or III lung cancer.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 2 years to measure the complete pathologic response.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04991025
Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~60 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:CisplatinPemetrexedGemcitabineCarboplatinCertolizumabNivolumab
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants complete pathologic response (CPR)
Measured over up to 2 years
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Paul Paik, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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.
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
What this trial measures
- Participants complete pathologic response (CPR)up to 2 years
To evaluate the complete pathologic response (CPR) of participants with stage II-III lung cancers who receive treatment with neoadjuvant platinum-based chemotherapy + certolizumab pegol. Major pathologic response (MPR) is defined as 10% or less residual viable tumor after neoadjuvant therapy