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

Roche

Status: Completed

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib 150 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT01836133

ML28282

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Erlotinib 150 mg

Description:

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

Treatment:

Drug: Erlotinib 150 mg