NCT01790217

Brief Summary

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

February 11, 2013

Last Update Submit

November 1, 2016

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate at 18 months

    3.5 years

Secondary Outcomes (8)

  • Response rate (complete response/partial response) by type of mutation

    3.5 years

  • Percentage of patients with remission

    3.5 years

  • Progression-free survival (overall/stratified)

    3.5 years

  • Overall survival (overall/stratified)

    3.5 years

  • Tolerability: Incidence of fatigue, rash, diarrhea

    3.5 years

  • +3 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with locally advanced or metastatic EGFR mutation positive non-small cell lung cancer

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
  • Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Oldenburg, 26121, Germany

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(1)