Clinical trial · Interventional
Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib. Intervention: Drug: Celecoxib
- interventionNames
- Drug: Celecoxib
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 3 year overall survival
Secondary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 3 year progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * • 18-70 years old, male or female * Histological or cytological evidence of NSCLC. * Unresectable Stage III NSCLC. * Karnofsky score: at least 70. * Estimated survival: at least 6 months * Not receiving radiotherapy or combined modality therapy to treat another malignancy. * No history of active gastric ulcer, active GI bleeding, or renal failure. * No severe hypertension, cardiac disease, or diabetes mellitus * Normal blood routine and chemical tests * Patients or guardian must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * • Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer * Extensive distant metastases * Pregnancy or in lactation * Allergic to Sulfonamides, NSAIDS or Celebrex * Routine use of NSAIDS such as high dose of Aspirin * History of cardiovascular diseases including: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months. * Abnormal coagulation or history of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels.
References
Publications (1)
- DERIVEDBi 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. PMID 31851351