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Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.


N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV)
non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in
clinical practice according to RECIST criteria

- EGFR mutation-positive disease according to local laboratory testing

- Patients on treatment with Tarceva monotherapy as first-line treatment according to
the physician's usual practice

Exclusion Criteria:

- Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or
adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to
receiving Tarceva

- Participation in another clinical study

- Patients could have received radiotherapy as long as the irradiated lesion was not
the only lesion for evaluating response and a long as the radiotherapy was completed
before initiating Tarceva treatment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios (AEMPS)

Study ID:

ML28361

NCT ID:

NCT01723878

Start Date:

July 2013

Completion Date:

July 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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