The Continuation of Erlotinib

The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130779

Enrollment

Registered

2010-05-26

Start date

2009-08-31

Completion date

Unknown

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, Erlotinib, brain metastasis

Brief summary

Newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. Given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.

Interventions

DRUGErlotinib (TARCEVA®)

Erlotinib 150mg/day, everyday

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or cytologically proven non small cell lung cancer 2. New developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib 3. patients who are receiving erlotinib as salvage therapy 4. At least one unidimensionally measurable lesion with a diameter \> 10mm using brain MRI 5. at least on unidimensionally measurable or evaluable lesion 6. male or female patients aged \>18 years 7. ECOG performance status 0-2 8. Adequate hematologic function 9. adequate renal function 10. adequate hepatic function

Exclusion criteria

1. leptomeningeal metastases 2. acute severe infection requiring antibiotic therapy 3. significant cardiovascular disease 4. uncontrolled DM 5. severe ophthalmologic disease

Design outcomes

Primary

Measure	Time frame
progression free survival	6 months

Secondary

Measure	Time frame
overall survival	6 months
response rate	6 months
time to treatment failure	6 months
toxicity profiles	6 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026