A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-07-31

Brief Summary

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This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.

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Detailed Description

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Conditions

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Carcinoma，Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib

Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Erlotinib 150 mg oral doses will be administered daily.

Interventions

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Erlotinib

Erlotinib 150 mg oral doses will be administered daily.

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
* Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy greater than or equal to (≥) 12 weeks
* Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
* Adequate hematological , liver and renal function

Exclusion Criteria

* Known hypersensitivity to erlotinib or any of its excipients
* Squamous non-small cell or small cell tumors or absence of histological report
* Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
* Prior exposure to inhibitors of EGFR
* Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
* Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
* Radical radiotherapy with curative intent within 28 days prior to enrollment
* Any active non-controlled systemic disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No