Clinical trial · Interventional
A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
NCT00743938CI-TRIAL-00019421completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
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 |
|---|---|---|---|
| BMS-690514 | Drug | — | UNRESOLVED |
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A1
- interventionNames
- Drug: BMS-690514
- type
- ACTIVE_COMPARATOR
- label
- B2
- interventionNames
- Drug: Erlotinib
Primary outcomes (1)
- measure
- To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
- timeFrame
- CT/MRI at baseline and every 6 weeks for 36 weeks
Secondary outcomes (6)
- measure
- To compare the overall survival between BMS-690514 and erlotinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG PS of 0 or 1 * Histologically confirmed NSCLC * Adequate amount of tumor (archived or fresh) for biomarker evaluation * Received one to two regimens of chemotherapy (with at least one platinum-containing) * Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min * Stable control of blood pressure on agents other than calcium channel blockers * Women of child-bearing potential must avoid pregnancy or maintain adequate contraception * Must be able to swallow pills and take the medications at the same time every day on an empty stomach Exclusion Criteria: * ECOG PS 2 or greater * Women unwilling to avoid pregnancy or use adequate contraception * Symptomatic brain metastases * Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months) * History of hemoptysis greater than 10 mL/day * Significant cardiovascular disease * Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease * History of use of other TKIs * Uncontrolled hypertension * HIV+
References
Publications (0)
Data not yet available
No reference posted for this study.