Clinical trial · Interventional
APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer 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)
This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.
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 |
|---|---|---|---|
| Recurrent Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apricoxib/erlotinib | Drug | — | UNRESOLVED |
| erlotinib/placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: apricoxib/erlotinib
- type
- PLACEBO_COMPARATOR
- label
- B
- interventionNames
- Drug: erlotinib/placebo
Primary outcomes (1)
- measure
- Time to Disease Progression (TDP)
- timeFrame
- Baseline and every other cycle.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion) * Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible. * Measurable disease by RECIST * Greater than or equal to 18 years of age * ECOG PS of 0 or 1 Exclusion Criteria: * Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment * Evidence of NYHA class III or greater cardiac disease * History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months * Known HIV infection or AIDS * Symptomatic CNS metastases * Pregnant or nursing women * Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs. * History of upper GI bleeding, ulceration, or perforation * Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC * Previous anti-EGFR kinase therapy
References
Publications (1)
- DERIVEDGitlitz BJ, Bernstein E, Santos ES, Otterson GA, Milne G, Syto M, Burrows F, Zaknoen S. A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Apr;9(4):577-82. doi: 10.1097/JTO.0000000000000082. PMID 24736085