An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-01-31

Brief Summary

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This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.

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Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Erlotinib 150 mg

Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.

Erlotinib 150 mg

Intervention Type DRUG

Interventions

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Erlotinib 150 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult participants, \>/= 18 years of age
* Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate hematologic, renal and liver function
* Participant initiating treatment with Tarceva according to the Summary of Product Characteristics

Exclusion Criteria

* Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
* Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
* Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No