Actively Recruiting
Phase 2 Trial of Neoadjuvant Nivolumab, Platinum-based Chemotherapy, and Certolizumab in Resectable Stage II-III Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-10-20
60
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the drug certolizumab to standard chemotherapy and nivolumab can improve treatment outcomes for people with stage II-III lung cancers that can be surgically removed. This phase II study focuses on lung adenocarcinoma and squamous cell carcinoma to see if combining certolizumab with the usual treatment reduces cancer-related inflammation and helps shrink tumors more effectively than chemotherapy and nivolumab alone. Participants will receive a combination of platinum-based chemotherapy, nivolumab, and certolizumab before surgery. Those with lung adenocarcinoma receive cisplatin and pemetrexed, while those with squamous cell carcinoma get cisplatin and gemcitabine, both on a 21-day cycle. Certolizumab is given as a 400mg injection under the skin within one hour before chemotherapy starts on day 1 of each cycle. Some participants may receive carboplatin instead of cisplatin if not eligible for cisplatin. The study includes separate groups for adenocarcinoma and squamous cell carcinoma patients. During the study, participants will be monitored for up to two years to assess their pathological response to the treatment. Researchers will evaluate tumor shrinkage and treatment effects using various tests and scans. Participants will undergo regular health assessments to monitor safety and treatment effects. The study aims to determine how well the combined therapy works and its impact on surgical outcomes and overall disease control.
CONDITIONS
Brief Title
Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated stage II-III non-small cell lung cancer with operable and resectable disease as determined by a thoracic surgeon
- Histologic confirmation of lung cancer at the study center
- Age 18 years or older
- Karnofsky Performance Status of 70 or higher
- Adequate bone marrow, liver, and kidney function based on specific blood test thresholds
- Negative tuberculosis test
- Negative pregnancy test for women of childbearing potential within 14 days before treatment
- Willingness to use effective contraception during treatment and for at least 5 months after
- At least one measurable tumor site
- Ability to provide informed consent
- Negative HIV test or stable HIV with specific criteria
- Negative hepatitis B surface antigen and core antibody tests or negative hepatitis B virus DNA test if required
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessment
You will not qualify if you...
- Presence of an FDA-approved targeted therapy for specific genetic lung cancer types
- Allergic reactions to platinum-based chemotherapy
- Prior use of TNF-alpha inhibitors
- Recent or planned use of systemic immunosuppressive medications, with some exceptions
- Active or history of autoimmune diseases or immune deficiencies, with defined exceptions
- History of certain lung diseases or active pneumonitis
- Significant hearing loss
- Current infections requiring treatment, including active or latent tuberculosis
- Significant recent cardiovascular disease or unstable heart conditions
- Recent major surgery or planned surgery during the study
- Active hepatitis B or C infection
- Known HIV infection requiring antiretroviral medications or AIDS
- Active herpes zoster infection
- Current antiviral treatment for hepatitis B
- Non-healed infected skin ulcers
- Uncontrolled high calcium levels in the blood
- Prior history of other malignancies with certain exceptions
- Severe infection within 4 weeks before treatment
- Recent therapeutic oral or IV antibiotics use, except for prophylactic antibiotics
- Prior allogeneic stem cell or organ transplantation
- Other medical conditions that increase risk or affect study results
- Recent live attenuated vaccines
- Prior investigational therapy within 28 days
- Previous treatment with immune checkpoint inhibitors or CD137 agonists
- Known hypersensitivity to study drug components
- Pregnancy, breastfeeding, or planning pregnancy during and for specified times after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 21-day cycles prior to surgery
Participants receive neoadjuvant platinum-based chemotherapy combined with nivolumab and certolizumab before surgery. Chemotherapy regimens vary based on lung cancer subtype and eligibility, administered in 21-day cycles.
Visits on days 1 and 8 of each 21-day cycle for drug administration
Duration - Until surgery is completed, typically shortly after treatment cycles
Participants undergo surgical removal of lung cancer after completing neoadjuvant treatment.
1 surgical hospitalization (in-person)
Duration - Up to 2 years
Participants are monitored after surgery to assess recovery and treatment response.
Regular follow-up visits for monitoring and assessment
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
Research Team
P
Paul Paik, MD
M
Matthew Bott, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here