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.

Hoffmann-La Roche43 sites in 1 country144 target enrollmentDecember 30, 2013

ConditionsNon-Squamous Non-Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 144
Locations: 43
Primary Endpoint: 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
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 30, 2013

End Date

June 20, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 3 years

Secondary Outcomes

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