CompletedNCT01194050Updated Nov 2, 2016

An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer

An observational study in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 289
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Non-Squamous Non-Small Cell Lung Cancer

Browse trials for

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 289 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Non small cell lung cancer patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Not willing or not able to sign written informed consent form

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 289 participants (actual)

Groups and cohorts

Cohort

What researchers measure

Primary outcomes

Overall survival at 1 year
Time frame: 12 months

Secondary outcomes

Tolerability of Tarceva in daily clinical practice under routine conditions
Time frame: 12 months
Efficacy of Tarceva in daily clinical practice under routine conditions
Time frame: 12 months
Reproducibility of the results of the controlled SATURN study
Time frame: 12 months

Study locations

1 site

Villingen-Schwenningen, 78052, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01194050
Lead sponsor: Hoffmann-La Roche
Responsible party: Sponsor
First posted: Sep 2, 2010
Start date: Jun 2010
Primary completion: Jul 2013
Completion: Jul 2013
Last update: Nov 2, 2016

Study contacts

Clinical Trials

study director · Hoffmann-La Roche

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Hoffmann-La Roche

Start the discussion