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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00556322
First received: November 9, 2007
Last updated: March 3, 2014
Last verified: March 2014

November 9, 2007
March 3, 2014
March 2006
June 2012   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Overall survival
Complete list of historical versions of study NCT00556322 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: progression-free survival; time to progression; objective response; duration of response; Safety: adverse events; laboratory values; Pharmacokinetics: population pharmacokinetic analysis
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
An 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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Alimta or Taxotere
    500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
  • Drug: erlotinib [Tarceva]
    150mg po daily
  • Experimental: 1
    Intervention: Drug: erlotinib [Tarceva]
  • Active Comparator: 2
    Intervention: Drug: Alimta or Taxotere
Ciuleanu T, Stelmakh L, Cicenas S, Miliauskas S, Grigorescu AC, Hillenbach C, Johannsdottir HK, Klughammer B, Gonzalez EE. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012 Mar;13(3):300-8. Epub 2012 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
417
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Australia,   Austria,   Belgium,   Canada,   Chile,   China,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Venezuela,   Lithuania,   Malaysia,   New Zealand,   Poland,   Romania,   Russian Federation,   Slovakia,   Slovenia,   South Africa,   Spain,   Ukraine,   United Kingdom
 
NCT00556322
BO18602
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP