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A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

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ClinicalTrials.gov Identifier: NCT01342965
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 26, 2011
First Posted Date  ICMJE April 27, 2011
Results First Submitted Date  ICMJE February 5, 2015
Results First Posted Date  ICMJE February 24, 2015
Last Update Posted Date February 24, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
Investigator-assessed Duration of Progression-free Survival [ Time Frame: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months) ]
The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 21 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
  • Percentage of Responders as Assessed by the Investigator [ Time Frame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) ]
    A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.
  • Percentage of Participants With Disease Control [ Time Frame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) ]
    A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.
  • Duration of Response [ Time Frame: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) ]
    Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
  • Overall Survival [ Time Frame: Baseline to the end of the study (3 years, 1 month) ]
    Overall survival was defined as the time from the date of randomization to the date of death from any cause.
  • Safety: Incidence of Adverse Events [ Time Frame: 36 months ]
  • Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire [ Time Frame: approximately 21 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Objective response rate (complete response + partial response) [ Time Frame: approximately 21 months ]
  • Disease control rate (complete response + partial response + stable disease) [ Time Frame: approximately 21 months ]
  • Duration of response [ Time Frame: approximately 21 months ]
  • Overall survival [ Time Frame: 36 months ]
  • Safety: Incidence of adverse events [ Time Frame: 36 months ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) questionnaire [ Time Frame: approximately 21 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
Official Title  ICMJE A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors
Brief Summary This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Erlotinib
    Erlotinib was supplied as tablets.
    Other Name: Tarceva
  • Drug: Chemotherapy
    Cisplatin and gemcitabine were locally sourced with commercial products.
Study Arms  ICMJE
  • Experimental: Erlotinib
    Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
    Intervention: Drug: Erlotinib
  • Active Comparator: Chemotherapy
    Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
    Intervention: Drug: Chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2014)
217
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2011)
150
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult participants, ≥ 18 years of age.
  • Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
  • Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
  • Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
  • European Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

  • Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
  • Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
  • Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
  • Any inflammatory changes of the surface of the eye.
  • ≥ Grade 2 peripheral neuropathy.
  • History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
  • Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
  • Human immunodeficiency virus (HIV) infection.
  • Pregnant, nursing, or lactating women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Malaysia,   Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01342965
Other Study ID Numbers  ICMJE YO25121
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2015

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