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NCT Number: NCT01996332

A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alcoy, Alicante, Spain

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;
  • locally advanced or metastatic NSCLC (Stage IIIB or IV);
  • not a candidate for curative surgery or radical chemotherapy;
  • no brain metastases, or clinically stable metastases for >=2 months.

Exclusion criteria

  • radiotherapy over the previous 2 weeks;
  • weight loss >10% in the previous 6 weeks.

Treatment and study plan

erlotinib [Tarceva]

Drug

150 mg/day until progressive disease or unacceptable toxicity

Primary outcomes

  1. Time to Disease Progression or Death by Line of Treatment

    Time frame: Baseline, every 6-8 weeks up to 3 years until disease progression or death

    Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.

Secondary outcomes

  1. Percentage of Participants Achieving Clinical Benefit by Line of Treatment

    Time frame: Baseline, every 6-8 weeks up to 3 years or until death

    Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

  2. Overall Survival (OS) by Line of Treatment

    Time frame: Baseline, every 6-8 weeks up to 3 years, or until death

    Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Nov 27, 2013
Registry last updated
Jul 10, 2014

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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