Clinical trial · Interventional
Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy
NCT00072631CI-TRIAL-00031595completedPhase 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 determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Failed Prior Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tarceva (Trademark) (erlotinib HCl, OSI-774) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1 erlotinib
- interventionNames
- Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Primary outcomes (1)
- measure
- Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Feasibility of correlating objective response rate and duration of response to grade of rash
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological). * Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer. * Measurable disease per RECIST criteria. * Adequate bone marrow, hepatic and renal function. Exclusion Criteria: * Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years. * Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days. * Known hypersensitivity to minocycline. * History of serious cardiac disease that is not controlled. * Serious eye conditions. * Prior treatment with inhibitors of EGFR of any kind.
References
Publications (0)
Data not yet available
No reference posted for this study.