Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Non-Squamous Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2016

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT01836133

Start Date

May 1 2013

End Date

January 1 2016

Last Update

May 4 2017

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Clinical Center of Serbia; Institute For Pulmology

Belgrade, Serbia, 11000

2

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, Serbia, 11000

3

Military Medical Academy; Clinic for Pulmonology

Belgrade, Serbia, 11000

4

Institute for pulmonary diseases of Vojvodina

Kamenitz, Serbia, 21204