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OpenTrials
Completed

NCT Number: NCT01066884

A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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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

Interventional

Phase

Phase 4

Primary location

Balashikha, Russia

Loading trial locations.

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;
  • inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
  • ECOG performance status of 0-3;
  • previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

Exclusion criteria

  • prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
  • unstable systemic disease;
  • any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
  • any significant ophthalmologic abnormality.

Treatment and study plan

erlotinib [Tarceva]

Drug

150mg po daily

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Length of patient on study (length of time of patient on study determined by investigator)

Secondary outcomes

  1. Best Response Rate per investigator assessment

    Time frame: Length of patient on study (length of time of patient on study determined by investigator)

  2. Time to Progression (TTP)

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

  3. Overall survival

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 10, 2010
Registry last updated
Aug 24, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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