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Clinical Trials (PDQ®)

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Clinical Trials (PDQ®)

A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentCompleted18 and overPharmaceutical / IndustryBO18192
NCT00556712

Trial Description

Summary

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Eligibility Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • histologically documented, locally advanced , recurrent or metastatic NSCLC;
  • measurable disease;
  • no disease progression after 4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

  • unstable systemic disease;
  • any other malignancies in the last 5 years.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical TrialsStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00556712
ClinicalTrials.gov processed this data on November 23, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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