NCT01194050

Brief Summary

This observational study will investigate the tolerability and efficacy of Tarceva (erlotinib) in daily clinical practice under routine conditions in patients with locally advanced or metastatic non small cell lung cancer. Data will be collected for approximately 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

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

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.1 years

First QC Date

September 1, 2010

Last Update Submit

November 1, 2016

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival at 1 year

    12 months

Secondary Outcomes (3)

  • Tolerability of Tarceva in daily clinical practice under routine conditions

    12 months

  • Efficacy of Tarceva in daily clinical practice under routine conditions

    12 months

  • Reproducibility of the results of the controlled SATURN study

    12 months

Study Arms (1)

Cohort

Eligibility Criteria

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

Non small cell lung cancer patients

You may qualify if:

  • Adult patients with locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy

You may not qualify if:

  • Not willing or not able to sign written informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Villingen-Schwenningen, 78052, 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

September 1, 2010

First Posted

September 2, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(1)