Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04991025

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-10-20

60

Participants Needed

7

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Untreated stage II-III non-small cell lung cancer with operable and resectable disease confirmed by a thoracic surgeon
  • Histologic confirmation of lung cancer at MSKCC
  • Age 18 years or older
  • Karnofsky Performance Status of 70 or higher
  • Adequate bone marrow, liver, and kidney function as defined by specific blood count and chemistry levels
  • Negative tuberculosis test (PPD or interferon-gamma release assay)
  • Negative pregnancy test for women of child-bearing potential within 14 days before treatment
  • Willingness to use effective contraception during treatment and for 5 months after
  • At least one measurable tumor site according to RECIST 1.1 criteria
  • Ability to provide written informed consent
  • Negative HIV test or stable HIV on therapy with adequate CD4 count and undetectable viral load
  • Negative hepatitis B surface antigen and core antibody tests, or negative HBV DNA if core antibody positive
  • Prior or concurrent malignancies allowed if they do not interfere with safety or treatment assessment
Not Eligible

You will not qualify if you...

  • Presence of an FDA-approved targeted therapy for specific genomic mutations in NSCLC
  • Allergy or hypersensitivity to platinum agents, certolizumab pegol, nivolumab, or components of their formulations
  • Prior use of TNF-alpha inhibitors
  • Recent or anticipated use of systemic immunosuppressive medications within 2 weeks before treatment, with certain exceptions
  • Active or history of autoimmune disease or immune deficiency, with some controlled thyroid or diabetes exceptions
  • History of severe lung conditions like idiopathic pulmonary fibrosis or drug-induced pneumonitis
  • Significant hearing loss (grade 2 or higher)
  • Active infections requiring treatment, including active or untreated tuberculosis
  • Significant cardiovascular disease or recent major surgery
  • Acute or chronic hepatitis B or C infection
  • Known HIV infection requiring antiretroviral medication or AIDS
  • Active herpes zoster infection or current antiviral therapy for hepatitis B
  • Non-healed infected skin ulcers
  • Uncontrolled high calcium levels
  • Prior malignancies with high risk of metastasis or death
  • Severe infections within 4 weeks before treatment
  • Recent therapeutic antibiotic treatment within 2 weeks
  • Prior allogeneic stem cell or solid organ transplant
  • Any condition that increases risk or interferes with treatment or results
  • Use of live vaccines within 4 weeks before or during treatment and for 5 months after last nivolumab dose
  • Treatment with investigational therapy within 28 days before treatment
  • Prior treatment with CD137 agonists or immune checkpoint inhibitors
  • Recent treatment with systemic immunostimulatory agents
  • History of severe allergic reactions to chimeric or humanized antibodies
  • Pregnancy, breastfeeding, or intention to become pregnant during treatment and specified periods after treatment

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

P

Paul Paik, MD

CONTACT

M

Matthew Bott, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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