PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01659970

Enrollment

152

Registered

2012-08-08

Start date

2012-06-30

Completion date

2014-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Brief summary

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy * Patients for whom the treating physician has decided to initiate treatment with Tarceva

Exclusion criteria

* Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component * Current participation in a clinical trial evaluating an anticancer treatment

Design outcomes

Primary

Measure	Time frame
Progression-free survival	2 years

Secondary

Measure	Time frame
Clinical/demographic patients characteristics at baseline	2 years
Treatment schedules: Dose/duration/modifications/interruptions	2 years
Overall survival	2 years
Safety: Incidence of adverse events	2 years
Quality of life: FACT-L version 4 questionnaire	2 years

Countries

France

Outcome results