An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy (TIME)

Roche

Status: Completed

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Observational

Funder types: Industry

Identifiers

NCT01664533

ML25708

Details and patient eligibility

About

This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 years of age.
• Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
• Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).

Exclusion criteria

• Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
• Contraindication for Tarceva according to the Summary of Product characteristics.

Trial design

57 participants in 1 patient group

Erlotinib

Description:

Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.

Treatment:

Drug: Erlotinib