Clinical trial NCT01161173: An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer
Official title: A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a "Real Life" Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.

Brief summary: This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Written informed consent.
* Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
* Measurable disease (Response Evaluation Criteria In Solid Tumors).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Prior course of standard systemic chemotherapy.

Exclusion Criteria:

- Contra-indications to treatment with Tarceva.

Primary outcomes:
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
timeFrame: Baseline to the end of the study (up to 4 years, 4 months)
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: Baseline to the end of the study (up to 4 years, 4 months)
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 4 years, 4 months)
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 4 years, 4 months)
measure: Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
timeFrame: Baseline to the end of the study (up to 4 years, 4 months)
measure: Percentage of Participants Who Developed Rash
timeFrame: Baseline to the end of the study (up to 4 years, 4 months)
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Arlon
country: Belgium
city: Bonheiden
country: Belgium
city: Bouge
country: Belgium
city: Boussu
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Chimay
country: Belgium
city: Duffel
country: Belgium
city: Edegem
country: Belgium
city: Frameries
country: Belgium
city: Genk
country: Belgium
city: Gilly
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Liège
country: Belgium
city: Marche-En-Famenne
country: Belgium
city: Mons
country: Belgium
city: Namur
country: Belgium
city: Oostende
country: Belgium
city: Ottignies
country: Belgium
city: Roeselare
country: Belgium
city: Seraing
country: Belgium
city: Sint Niklaas
country: Belgium
city: Tournai
country: Belgium
city: Turnhout
country: Belgium
city: Verviers
country: Belgium
city: Vilvoorde
country: Belgium
city: Wilrijk
country: Belgium
city: Differdange
country: Luxembourg
city: Esch-alzette
country: Luxembourg
city: Luxembourg
country: Luxembourg
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: