Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Summary

Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP) regimen is one of the most commonly used regimens. However, the prognosis of these patients is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote chemosensitivity and radiosensitivity of tumor cells in preclinical trials. This is a single-institution, open-label, randomized phase II trial of celecoxib administered concurrently with cisplatin, etoposide, and radiation therapy in patients with locally advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.

Timeline

Start

2011-12

Primary completion

2014-12

Completion

2016-12

Outcome

Missed primary endpoint

paper adding celecoxib to concurrent chemoradiation did not improve survival. PMID 31851351 ↗

Publications

• Bi N, Liang J, Zhou Z, Chen D, Fu Z, Yang X, Feng Q, Hui Z, Xiao Z, Lv J, Wang X, Zhang T, Wang X, Deng L, Wang W, Wang J, Liu L, Hu C, Wang L. Effect of Concurrent Chemoradiation With Celecoxib vs Concurrent Chemoradiation Alone on Survival Among Patients With Non-Small Cell Lung Cancer With and Without Cyclooxygenase 2 Genetic Variants: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918070. doi: 10.1001/jamanetworkopen.2019.18070.

Drugs

Indications