A Study of Tarceva (Erlotinib) Following Platinum-Based 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:
NCT00556712
First received: November 9, 2007
Last updated: March 3, 2014
Last verified: March 2014

November 9, 2007
March 3, 2014
January 2006
November 2010   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Efficacy,Progression- free survival
Complete list of historical versions of study NCT00556712 on ClinicalTrials.gov Archive Site
Overall survival, time to progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Efficacy:Overall survival; correlation of Tumor tissue biologic and genimic markers with clinical outcome: time to progression
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: erlotinib [Tarceva]
    150mg po daily
  • Drug: Placebo
    po daily
  • Experimental: 1
    Intervention: Drug: erlotinib [Tarceva]
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczésna A, Juhász E, Esteban E, Molinier O, Brugger W, Melezínek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
892
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Australia,   Austria,   Belgium,   Canada,   Chile,   China,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Venezuela,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Slovakia,   Slovenia,   South Africa,   Spain,   Ukraine,   United Kingdom
 
NCT00556712
BO18192
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