A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00883779
First received: April 15, 2009
Last updated: July 7, 2014
Last verified: July 2014

April 15, 2009
July 7, 2014
April 2009
January 2016   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven--tumor assessments every 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00883779 on ClinicalTrials.gov Archive Site
  • Objective response rate; duration of response; time to progression; overall survival [ Time Frame: Event driven--tumor assessment every 8 weeks ] [ Designated as safety issue: No ]
  • Non-progression rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • AEs, SAEs, laboratory data [ Time Frame: At each clinic visit throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of sequential treatment wi th Tarceva or placebo, plus platinum-based therapy, as first line treatment in p atients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or place bo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then follo wed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 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 on days 15-28 of each 4 week cycle until disease progression
  • Drug: Placebo
    po on days 15-28 of each 4 week cycle until disease progression
  • Drug: gemcitabine
    1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles
  • Drug: Platinum chemotherapy (cisplatin or carboplatin)
    cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles
  • Experimental: 1
    Interventions:
    • Drug: erlotinib [Tarceva]
    • Drug: gemcitabine
    • Drug: Platinum chemotherapy (cisplatin or carboplatin)
  • Placebo Comparator: 2
    Interventions:
    • Drug: Placebo
    • Drug: gemcitabine
    • Drug: Platinum chemotherapy (cisplatin or carboplatin)
Wu YL, Lee JS, Thongprasert S, Yu CJ, Zhang L, Ladrera G, Srimuninnimit V, Sriuranpong V, Sandoval-Tan J, Zhu Y, Liao M, Zhou C, Pan H, Lee V, Chen YM, Sun Y, Margono B, Fuerte F, Chang GC, Seetalarom K, Wang J, Cheng A, Syahruddin E, Qian X, Ho J, Kurnianda J, Liu HE, Jin K, Truman M, Bara I, Mok T. Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): a randomised, double-blind trial. Lancet Oncol. 2013 Jul;14(8):777-86. doi: 10.1016/S1470-2045(13)70254-7. Epub 2013 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
451
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced (stage IIIB/IV)non-small cell lung cancer;
  • measurable disease;
  • ECOG Performance Status 0 or 1.

Exclusion Criteria:

  • prior exposure to agents directed at the HER axis;
  • prior chemotherapy or systemic anti-tumor therapy after advanced disease;
  • unstable systemic disease;
  • any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
  • brain metastasis or spinal cord compression.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Indonesia,   Korea, Republic of,   Philippines,   Taiwan,   Thailand
 
NCT00883779
MO22201
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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