Clinical trial · Interventional
Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients
A Randomized, Double Blind, Placebo Controlled Phase III Trial Evaluating the Role of Adjuvant Celecoxib in Completely Resected, High-Risk (pN1-2) Non-Small Cell Lung Cancer (NSCLC) Patients
- 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)
The aim of the study is to assess the influence of celecoxib on relapse-free survival in completely resected patients with poor prognosis indicated by metastatic involvement of intrapulmonary/hilar (pN1) or ipsilateral mediastinal (pN2) lymph nodes. Celecoxib, a selective oral COX-2 inhibitor, was found to exert significant anti-proliferative activity against a variety of tumor cell lines in vitro, including NSCLC. COX-2 is frequently up-regulated in NSCLC cell lines and archival tumor samples. Its high expression was also correlated with poor prognosis of the patients. A clinical trial addressing the role of celecoxib as adjuvant treatment in radically operated patients with high risk of relapse is warranted.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- time to progression
Secondary outcomes (2)
- measure
- overall survival
- measure
- toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility criteria: * Completely resected (R0), histologically confirmed NSCLC with pathological T1-T3 category and pathological proof of N1 or N2 disease * Adequate pre-surgical disease assessment (chest CT and upper abdominal CT - mandatory; mediastinoscopy or PET mandatory if clinical N2 is suspected on chest CT; other examinations according to signs and symptoms to exclude metastatic disease) * Adequate lymph node sampling * Randomization between 14 and 42 days after surgery * Adequate post-surgical recovery * Age \> 18 years * WHO Performance Status 0 or 1 * Adequate liver and renal function (ALT \< 1.5 ULN, bilirubin within normal limits, creatinine \< 1.5 ULN) and adequate haematology (haemoglobin \>11g/dL, WBC\>2.000/L, PLT\>100.000/L) * Written informed consent * No previous treatment with chemotherapy * No histological diagnosis of SCLC or mixed NSCLC/SCLC type * No apparent involvement of mediastinal lymph nodes at preoperative staging (cN2) * No evidence of metastatic disease (M1) * Stable medical conditions (e.g. no myocardial infarction within 12 months, unstable angina, active psychiatric disorder) * No active infection * No history of malignancy other than basal-cell skin cancer or in situ cervical cancer * No history of severe renal or liver insufficiency * No history of a recent gastrointestinal bleeding or active ulcer disease or extensive gastro-intestinal surgery that may affect the drug absorption * No participation in any investigational study within 30 days prior to enrollment * No pregnancy or lactation or inadequate contraception * No known hypersensitivity to celecoxib, other COX-2 inhibitors or aspirin (aspirin triad) * No chronic use of NSAID's (selective inhibitors of COX-2 and non- selective COX inhibitors), acetylsalicylic acid (aspirin) nor oral steroids \>14 days during one month prior to surgery nor anticipated chronic use of the above drugs during the study
References
Publications (0)
Data not yet available