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Monoclonal Antibodies

Certolizumab for Lung Cancer

Phase 1

Waitlist Available

Led By Paul Paik

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if it's safe to give certolizumab with cisplatin and pemetrexed to people with lung cancer.

Eligible Conditions

Lung Cancer, Stage IV

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated does (MTD)

Secondary outcome measures

Immunohistochemical staining

Progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: certolizumab, cisplatin and pemetrexedExperimental Treatment3 Interventions

Patients will receive certolizumab with 6 cycles of cisplatin & pemetrexed. Cycle of chemo will be 3 weeks. Certolizumab will be adm in the following fashion: first dose administered at the time of treatment initiation, second dose will be given after 2 weeks of treatment, third dose after four weeks of treatment, & subsequent doses given every 4 weeks thereafter. Patients will be monitored for progression of disease using RECIST 1.1 with scans to be performed every 6 weeks. Posttreatment biopsies will be performed at the time of treatment discontinuation. Two dose levels of certolizumab will be tested, 200mg & 400mg. A non-therapeutic cohort of 10 patients with adenocarcinomas who will be undergoing standard of care treatment with platinum based chemotherapy + pemetrexed +/- bevacizumab will be consented for blood draws before each cycle of treatment. This blood will be analyzed for cytokines and will serve as a reference for the experimental arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Certolizumab

2014

Completed Phase 1

~30

cisplatin

1997

Completed Phase 3

~3290

pemetrexed

2005

Completed Phase 3

~5000

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,174 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,293 Total Patients Enrolled

Paul PaikPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this evaluation in terms of medical facilities?

"Currently, 6 hospitals are seeking volunteers for this clinical trial. As examples, Memorial Sloan Kettering Cancer Centre in New york City and the adjacent Phelps Memorial Hospital Center in Sleepy Hollow as well as the West Harrison facility in Harrison are all part of these medical trials."

Answered by AI

What other medical experiments have been performed using Certolizumab?

"Certolizumab was initially investigated by City of Hope Comprehensive Cancer Center in 1997, and since then 1,187 trials have been concluded. Currently there are 798 active studies taking place mainly in New york and New jersey."

Answered by AI

How is Certolizumab typically deployed in patient care?

"Certolizumab can help patients manage a range of medical conditions, including ovarian cancer, severe psoriatic arthritis and suboptimal responses to traditional remedies."

Answered by AI

What is the cap on participants for this study?

"Unfortunately, this research is no longer accepting candidates. It was initially posted on the first of April in 2014 and recently updated on the 26th of April 2022. However, there are still 791 active trials related to adenocarcinoma and an additional 798 studies recruiting participants for certolizumab treatment."

Answered by AI

How hazardous is Certolizumab for human health?

"As this is a Phase 1 trial, there are only limited indications of the safety and efficacy of Certolizumab. Thus, our team at Power rated it as a score of 1 on their scale."

Answered by AI

Are there still opportunities to take part in this investigation?

"At present, this trial is not recruiting new patients. It was initially launched on April 1st 2014 and the most recent update happened on April 26th 2022. If you are searching for other clinical trials related to adenocarcinoma, there are 791 currently open studies while Certolizumab has 798 active recruitment efforts going on."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas

2014. "Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02120807.