A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)


Tracking Information

Start Date  ICMJEMarch 2006
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)		Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: November 9, 2007)		Overall survival
Change HistoryComplete list of historical versions of study NCT00556322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 18, 2008)
  • PFS, time to progression, objective response, duration of response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: November 9, 2007)		Efficacy: progression-free survival; time to progression; objective respo

Descriptive Information

Brief Title  ICMJEA Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJEAn Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy
Brief Summary

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJENon-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: erlotinib [Tarceva]
    150mg po daily
  • Drug: Alimta or Taxotere
    500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: erlotinib [Tarceva]
  • 2: Active Comparator
    Intervention: Drug: Alimta or Taxotere

Recruitment Information

Estimated Enrollment  ICMJE650
Estimated Completion DateAugust 2014
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients >=18 years of age;
  • histologically documented, locally advanced or recurrent or metastatic NSCLC;
  • measurable disease;
  • disease progression during 1-4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

  • any other malignancies within the last 5 years;
  • unstable systemic disease.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO18602888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEAustralia,   Austria,   Belgium,   Canada,   Chile,   China,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   New Zealand,   Poland,   Romania,   Russian Federation,   Slovakia,   Slovenia,   South Africa,   Spain,   Ukraine,   United Kingdom,   Venezuela

Administrative Information

NCT ID  ICMJENCT00556322
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBO18602
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche