Clinical trial NCT01664533: An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy
Official title: Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.

Brief summary: This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
* Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).

Exclusion Criteria:

* Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
* Contraindication for Tarceva according to the Summary of Product characteristics.

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 2 years)
Secondary outcomes:
measure: Best Overall Response
timeFrame: Baseline to the end of the study (up to 2 years)
measure: Overall Survival
timeFrame: Up to 2 years
measure: Percentage of Participants Who Developed Rash
timeFrame: Up to 2 years
measure: Percentage of Participants Who Developed Diarrhea
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Boussu
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Dendermonde
country: Belgium
city: Duffel
country: Belgium
city: Edegem
country: Belgium
city: Frameries
country: Belgium
city: Genk
country: Belgium
city: Gilly
country: Belgium
city: Gosselies
country: Belgium
city: Liege
country: Belgium
city: Mons
country: Belgium
city: Montegnée
country: Belgium
city: Namur
country: Belgium
city: Ottignies
country: Belgium
city: Roeselare
country: Belgium
city: Sint Niklaas
country: Belgium
city: Tournai
country: Belgium
city: Turnhout
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: