Clinical trial · Interventional
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
- 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 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.
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 |
|---|---|---|---|
| Doxycline | Drug | — | UNRESOLVED |
| erlotinib [Tarceva] | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Doxycline
- Drug: erlotinib [Tarceva]
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: erlotinib [Tarceva]
Primary outcomes (1)
- measure
- Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
- timeFrame
- Days 0, 14, 28 and Months 2, 3, and 4
- description
- Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, 18-75 years of age; * confirmed non-small cell lung cancer; * failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva. Exclusion Criteria: * rash of any etiology at study entry; * history of significant heart disease; * any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix); * history of allergic reactions to tetracyclines.
References
Publications (0)
Data not yet available