Your session is about to expire
← Back to Search
Alkylating agents
Certolizumab + Chemotherapy + Nivolumab for Lung Cancer
Phase 2
Recruiting
Led By Paul Paik, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Untreated stage II-III (AJCC 8th edition) non-small cell lung cancers with operable and resectable disease determined by a thoracic surgeon
Adequate bone marrow, liver and renal function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether adding the drug certolizumab to standard chemotherapy can help reduce inflammation and make the chemotherapy more effective.
Who is the study for?
This trial is for adults over 18 with stage II-III non-small cell lung cancer that can be surgically removed. They must have good performance status, proper organ function, no severe infections or allergies to the drugs used in the trial, and not be on immunosuppressive medication. Participants should not have other cancers or diseases that could affect results and must agree to use contraception.Check my eligibility
What is being tested?
The study tests if adding Certolizumab to standard chemotherapy (Gemcitabine, Cisplatin, Pemetrexed, Carboplatin) plus Nivolumab improves treatment outcomes for lung cancer patients who are candidates for surgery. It aims to see if this combination reduces inflammation and makes chemo more effective at shrinking tumors.See study design
What are the potential side effects?
Possible side effects include allergic reactions to drug components, infection risks due to immune system suppression by Nivolumab and Certolizumab, potential liver or kidney issues from chemotherapy agents like Cisplatin and Gemcitabine, as well as general fatigue and digestive problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is in stage II-III and can be surgically removed.
Select...
My bone marrow, liver, and kidneys are functioning well.
Select...
I do not have active hepatitis B.
Select...
I have at least one tumor that can be measured.
Select...
I am mostly able to care for myself.
Select...
I do not have HIV, or if I do, it is under control with treatment.
Select...
I have another cancer, but it won't affect this cancer treatment's safety or results.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants complete pathologic response (CPR)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Participants with resectable stage II-III lung cancers (squamous cell carcinoma)Experimental Treatment6 Interventions
This is a single arm phase II study of neoadjuvant platinum-based chemotherapy + nivolumab + certolizumab in participants with resectable stage II-III lung cancers. There will be separate adenocarcinoma and squamous cell carcinoma cohorts.
Group II: Participants with resectable stage II-III lung cancers (Adenocarcinoma)Experimental Treatment6 Interventions
This is a single arm phase II study of neoadjuvant platinum-based chemotherapy + nivolumab + certolizumab in participants with resectable stage II-III lung cancers. There will be separate adenocarcinoma and squamous cell carcinoma cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Gemcitabine
2017
Completed Phase 3
~2070
Nivolumab
2014
Completed Phase 3
~4750
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Certolizumab
2014
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,744 Total Patients Enrolled
Paul Paik, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for hepatitis B.I am currently being treated for an infection, but it's not thrush.You are allergic to Chinese hamster ovary cell products or any part of the nivolumab medication.I have active or untreated latent tuberculosis.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.My lung cancer is in stage II-III and can be surgically removed.Your disease must be confirmed by a special test at MSKCC.I am allergic to ingredients in Certolizumab pegol.I am allergic to components in platinum-based chemotherapy.My bone marrow, liver, and kidneys are functioning well.I have previously used a TNF-alpha inhibitor.I do not have active hepatitis B.I have had cancer before, but it was unlikely to spread or be fatal.I have at least one tumor that can be measured.You are allergic to platinum-based medications.I am mostly able to care for myself.I do not have HIV, or if I do, it is under control with treatment.You have uncontrolled or symptomatic high levels of calcium in your blood.I have open, infected wounds on my skin.I have not received any live vaccines in the last 4 weeks and won't during or for 5 months after my nivolumab treatment.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.You need to have a negative pregnancy test within 14 days before starting the treatment.I don't have any health issues that would make it unsafe for me to take a new drug.I have not had a severe infection in the last 4 weeks.My NSCLC has a genetic change treatable with FDA-approved drugs.I have a history of lung scarring or inflammation not caused by infections.You have tested negative for tuberculosis.I currently have an active shingles infection.I have another cancer, but it won't affect this cancer treatment's safety or results.I haven't had serious heart problems or irregular heartbeats in the last 3 months.I have not taken any strong antibiotics in the last 2 weeks.You have a current or past autoimmune disease or immune deficiency.I am 18 years old or older.I have Hepatitis B or C.I am on medication for HIV or have AIDS.You tested negative for hepatitis B surface antigen (HBsAg) during screening.You've had serious allergic reactions to certain types of medications made from proteins.I have moderate to severe hearing loss.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I have had a previous transplant of stem cells or an organ.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with resectable stage II-III lung cancers (Adenocarcinoma)
- Group 2: Participants with resectable stage II-III lung cancers (squamous cell carcinoma)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Certolizumab been cleared by the FDA?
"While there is some clinical data supporting Certolizumab's safety, its efficacy has yet to be proven, so it received a score of 2."
Answered by AI
Are new participants being permitted to join the research at this time?
"That is correct. The clinical trial mentioned is currently underway and looking for 60 individuals from 7 different locations. The information was published on October 19th, 2020 and was last edited on October 20th, 2020."
Answered by AI
What medical conditions does Certolizumab target?
"Certolizumab is an effective medical treatment for patients with urinary bladder cancer, small cell lung cancer (sclc), and advanced testicular cancer."
Answered by AI
How does Certolizumab compare to other treatments in similar clinical trials?
"City of Hope Comprehensive Cancer Center was the first to study certolizumab back in 1997 and, since then, 2581 trials have completed. As of now, there are 1479 ongoing studies, a majority of which are based in Uniondale, New jersey."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger