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

NCT01836133 | Completed Results

• 1 other identifier: ML28282
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.

  Approximately 3 years

Secondary Outcomes (2)

• Percentage of Participants With Overall Response

  Approximately 3 years

• Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)

  Baseline up to 3 years

Study Arms (1)

Erlotinib 150 mg

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

Drug: Erlotinib 150 mg

Interventions

Erlotinib 150 mg DRUG

Erlotinib 150 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer, with ECOG performance status of 0-1

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Clinical Center of Serbia; Institute For Pulmology

Belgrade, 11000, Serbia

Location

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, 11000, Serbia

Location

Military Medical Academy; Clinic for Pulmonology

Belgrade, 11000, Serbia

Location

Institute for pulmonary diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Nis; Clinic for pulmonary diseases Knez Selo

Knez-Selo, 18000, Serbia

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 4, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-03

Locations

SE (5)