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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

Efficacy and Safety of erLotinib (Tarceva® ) Therapy in patiEnts With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) , Subtype adEnocarcinoma, Who Have Good performaNce sTatus (PS 0-1) - ELEMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836133
• Other study ID #: ML28282
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: November 1, 2016
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Medicines and Medical Devices of Serbia
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 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

• Patient 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		approximately 2.5 years	No
Secondary	Response rate		approximately 2.5 years	No
Secondary	Safety: Incidence of adverse events (including SAEs and AEs of special interest)		approximately 2.5 years	No