Clinical trial · Interventional
Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer
A Phase II Study to Determine the Efficacy of Tarceva® (Erlotinib Hydrochloride) With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)
NCT00871923CI-TRIAL-00053892completedPhase 2Results postedClinicalTrials.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 goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).
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 |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Tarceva (Erlotinib hydrochloride) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tarceva + RT
- description
- Tarceva (Erlotinib hydrochloride) + Radiation Therapy. Tarceva 150 mg by mouth every day beginning Day 1. Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
- interventionNames
- Drug: Tarceva (Erlotinib hydrochloride)
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Median Survival
- timeFrame
- End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months, assessed up to 2 years.
- description
- Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.
Secondary outcomes (1)
- measure
- Number of Participants With Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological confirmation of non-small cell lung cancer 2. Patients who have been treated in the past with stereotactic radiosurgery, stereotactic radiotherapy, GliaSite or surgical resection will be allowed to enroll in this study 3. A diagnostic contrast-enhanced MRI or CT scan must be performed, demonstrating brain metastases 4. Age 18-70 5. Patients must have KPS \>/= 70 6. Patients cannot be treated on any other treatment related protocols within 30 days prior to study entry or during participation in the study 7. No uncontrolled or symptomatic major medical illnesses or psychiatric impairments, such as Alzheimer's or schizophrenia 8. Screening Clinical Laboratory Values: ANC \>1500/ul, Platelets \>80,000/ul, baseline AST and/or ALT within normal limits (within 30 days of starting protocol treatment) 9. All women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (abstinence, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study. 10. Continued from #10: All women of child-bearing potential must have a negative serum pregnancy test and practice birth control while on study. 11. Patients must provide verbal and written informed consent to participate in the study. Exclusion Criteria: 1. Prior cranial radiation therapy, other than stereotactic radiosurgery, Stereotactic Radiotherapy or GliaSite. 2. Patients with known Acquired Immune Deficiency (AIDS), as regimens with tyrosine kinase inhibitors may pose a safety risk related to excess toxicity or interference with anti-viral effectiveness 3. Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant due to study drug 4. Patients with active connective tissue disorders, such as lupus or scleroderma
References
Publications (1)
- DERIVEDWelsh JW, Komaki R, Amini A, Munsell MF, Unger W, Allen PK, Chang JY, Wefel JS, McGovern SL, Garland LL, Chen SS, Holt J, Liao Z, Brown P, Sulman E, Heymach JV, Kim ES, Stea B. Phase II trial of erlotinib plus concurrent whole-brain radiation therapy for patients with brain metastases from non-small-cell lung cancer. J Clin Oncol. 2013 Mar 1;31(7):895-902. doi: 10.1200/JCO.2011.40.1174. Epub 2013 Jan 22. PMID 23341526