Clinical trial · Interventional
Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy
Cox-2-Inhibitor and Chemotherapy in Non-Small Cell Lung Cancer. A Prospective Randomized Double-Blind Study
- 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 primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Celecoxib
- description
- Four cycles of combination chemotherapy, usually with carboplatin + gemcitabine or carboplatin + vinorelbine, plus celecoxib 400 mg b.i.d. Treatment with celecoxib is continued after completion of chemotherapy. Maximum treatment duration is one year.
- interventionNames
- Drug: Celecoxib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Chemotherapy as in arm 1 plus placebo capsules, b.i.d.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). * Age at least 18 years. No upper age limit. * Disease stage IIIB or IV. * Performance status (WHO) 0-2 * Treatment with curative intent is not possible * No prior chemotherapy for the present disease * Planned treatment is palliative chemotherapy * WBC count at least 3.0, platelet count at least 100 * Bilirubin \< 1.5 \* upper reference limit (URL), ASAT and ALAT \< 3 \* URL (\<5 in case of liver metastases) * Calculated creatinine clearance at least 40 mg/ml * Informed oral and written consent Exclusion criteria: * Regular use of NSAID (except ASA at a dose of 50-100 mg daily) * Active duodenal ulcer, ongoing gastrointestinal bleeding or inflammatory bowel disease * Serious heart failure or serious liver disease * Hypersensitivity so sulfonamides * Pregnancy * Lactation
References
Publications (1)
- DERIVEDKoch A, Bergman B, Holmberg E, Sederholm C, Ek L, Kosieradzki J, Lamberg K, Thaning L, Ydreborg SO, Sorenson S; Swedish Lung Cancer Study Group. Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: a double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group. Eur J Cancer. 2011 Jul;47(10):1546-55. doi: 10.1016/j.ejca.2011.03.035. Epub 2011 May 10. PMID 21565487