This phase I clinical trial studies the side effects and the best dose of certolizumab when given together with cisplatin and pemetrexed disodium in treating patients with previously untreated lung cancer that has spread to other places in the body. Certolizumab reduces inflammation and may make chemotherapy more effective. It may also prevent tumor cells from spreading to new organs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving certolizumab together with cisplatin and pemetrexed disodium may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02120807.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) of the combination of certolizumab plus cisplatin and pemetrexed (pemetrexed disodium) in patients with untreated stage IV lung adenocarcinoma.
SECONDARY OBJECTIVES:
I. Objective response rate.
II. Progression-free survival (PFS).
CORRELATIVE OBJECTIVES:
I. To evaluate the on-target effect of certolizumab pegol on the tumor necrosis factor (TNF)-alpha/chemokine (C-X-C motif) ligand 1-2 (CXCL1-2)/S00A8/9 axis through serial quantification of serum TNF-alpha, CXCL1-2, and S100A8/9 concentrations.
II. To evaluate the on-target effect of certolizumab pegol on the TNF-alpha/CXCL1-2/S00A8/9 axis through immunohistochemical staining of these factors and related pathways using pre- and post-treatment biopsy specimens.
OUTLINE: This is a dose-escalation study of certolizumab.
Patients receive certolizumab subcutaneously (SC) on day 1 of weeks 1, 3, 5, 9, 13, and 17, and cisplatin intravenously (IV) and pemetrexed disodium IV on day 1 of weeks 1, 4, 7, 10, 13, and 16 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorPaul K Paik