ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01723878

Enrollment

144

Registered

2012-11-08

Start date

2013-12-30

Completion date

2017-06-20

Last updated

2017-09-11

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 patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.

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 locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria * EGFR mutation-positive disease according to local laboratory testing * Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice

Exclusion criteria

* Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized \>6 months prior to receiving Tarceva * Participation in another clinical study * Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment

Design outcomes

Primary

Measure	Time frame
Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics	3 years

Secondary

Measure	Time frame
One-year overall survival (from initiation of treatment to 12 months after disease progression)	3 years
Time to progression	3 years
Exposure (dosage/duration) with first-line Tarceva in clinical practice	3 years
Objective response rate, tumor assessments according to RECIST v1.1 criteria	3 years
Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression	3 years
Treatments used after disease progression in clinical practice	3 years
Safety: Incidence of adverse events	3 years

Countries

Spain

Outcome results