Clinical trial · Interventional
Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)
- 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)
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
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
- interventionNames
- Drug: celecoxib
Primary outcomes (1)
- measure
- Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week
- timeFrame
- 7 days
Secondary outcomes (3)
- measure
- OBD necessary to decrease PBL FOXP3 levels at 1 week
- timeFrame
- 7 dayd
- measure
- Function of CD4+ and CD25+ T-regulatory cells at 1 week
- timeFrame
- 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer * Stage IIIB or IV disease * Radiographically measurable disease * 18 and over * Performance status: ECOG 0-2 * Renal: Creatinine ≤ 2 mg/dL * Negative pregnancy test * Fertile patients must use effective contraception * More than 4 weeks since prior chemotherapy * Endocrine therapy: More than 4 weeks since prior corticosteroids; No concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids * Radiotherapy: More than 4 weeks since prior radiotherapy * More than 4 weeks since other prior anticancer therapy * More than 4 weeks since prior non-cytotoxic investigational agents * At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs) Exclusion Criteria: * pregnant or nursing * comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements * hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent * history of gastrointestinal ulceration, bleeding, or perforation * other concurrent cyclooxygenase-2 or -3 inhibitors * other concurrent NSAIDs
References
Publications (0)
Data not yet available