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: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Drug: Placebo
Drug: gemcitabine
Drug: Platinum chemotherapy (cisplatin or carboplatin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven--tumor assessments every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 441
Study Start Date: April 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg 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
Placebo Comparator: 2 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883779

Locations
China
Beijing, China, 101149
Beijing, China, 100142
Beijing, China, 100021
Guangzhou, China, 510060
Guangzhou, China, 510080
Hangzhou, China, 310016
Nanjing, China, 210008
Shanghai, China, 200030
Shanghai, China, 200433
Hong Kong
Hong Kong, Hong Kong
Hong Kong, Hong Kong, 852
Indonesia
Jakarta, Indonesia, 13230
Jogjakarta, Indonesia, 55284
Surabaya, Indonesia, 60286
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 411-769
Philippines
Manila, Philippines, 1000
Pasig City, Philippines, 1605
Quezon City, Philippines, 1104
Taiwan
Taichung, Taiwan, 407
Taipei, Taiwan, 100
Taipei, Taiwan
Taipei, Taiwan, 116
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00883779     History of Changes
Other Study ID Numbers: MO22201
Study First Received: April 15, 2009
Last Updated: August 11, 2014
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Carboplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014