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Completed

NCT Number: NCT01723878

ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Virgen de los Lirios; Servicio de Oncologia, Alcoy, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 3 years

Secondary outcomes

  1. Objective response rate, tumor assessments according to RECIST v1.1 criteria

    Time frame: 3 years

  2. One-year overall survival (from initiation of treatment to 12 months after disease progression)

    Time frame: 3 years

  3. Time to progression

    Time frame: 3 years

  4. Exposure (dosage/duration) with first-line Tarceva in clinical practice

    Time frame: 3 years

  5. Safety: Incidence of adverse events

    Time frame: 3 years

  6. Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression

    Time frame: 3 years

  7. Treatments used after disease progression in clinical practice

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2012
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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