A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940875
First received: July 6, 2009
Last updated: March 3, 2014
Last verified: March 2014

July 6, 2009
March 3, 2014
June 2009
September 2011   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: tumour assessment after every 2nd 4-week cycle ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940875 on ClinicalTrials.gov Archive Site
  • Overall response rate,disease control rate,duration of response,overall survival [ Time Frame: tumour assessment after every 2nd 4-week cycle, follow-up for survival at least 12 months ] [ Designated as safety issue: No ]
  • SAEs, AEs, laboratory parameters, vital signs, further/second line treatment. [ Time Frame: Throughout study, laboratory parameters assessed days 1,8,15 and 22 of cycles 1+2, days 1,8 and 15 of cycles 3-6 and every 4 weeks thereafter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: erlotinib [Tarceva]
    150mg po on days 15-28 of each 4 week cycle
  • Drug: gemcitabine
    1250mg/m2/day on days 1 and 8 of each 4 week cycle
  • Drug: gemcitabine
    1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
  • Experimental: 1
    Interventions:
    • Drug: erlotinib [Tarceva]
    • Drug: gemcitabine
  • Active Comparator: 2
    Intervention: Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=70 years of age or with ECOG PS of 2;
  • advanced (stage IIIB or IV)non-small cell lung cancer;
  • no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion Criteria:

  • active brain metastasis or spinal cord suppression;
  • unstable systemic disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00940875
ML22429
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