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Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00409006
First received: December 6, 2006
Last updated: August 13, 2010
Last verified: August 2010

December 6, 2006
August 13, 2010
February 2007
August 2009   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: Baseline to first observation of disease progression or death, 12 weeks up to 31 months ] [ Designated as safety issue: No ]
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
To compare progression-free survival in patients treated sequentially with pemetrexed plus cisplatin followed by gefitinib versus patients treated with pemetrexed and cisplatin followed by maintaining pemetrexed.
Complete list of historical versions of study NCT00409006 on ClinicalTrials.gov Archive Site
  • Number of Participants With Tumor Response [ Time Frame: Baseline to measured response or death, 12 weeks up to 31 months ] [ Designated as safety issue: No ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.
  • Duration of Response for Responders [ Time Frame: Time of response to progressive disease or death, 12 weeks up to 31 months ] [ Designated as safety issue: No ]
    The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.
  • Overall Survival [ Time Frame: Baseline to date of death from any cause, 12 weeks up to 31 months ] [ Designated as safety issue: Yes ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.
  • To compare the two treatment regimens as measured by:
  • tumor response rate,
  • Duration of response for responding patients,
  • Overall survival time.
  • To characterize the safety and adverse event profile of both treatment regimens.
Not Provided
Not Provided
 
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers
A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

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: Pemetrexed
    500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.
    Other Names:
    • LY231514
    • Alimta
  • Drug: Cisplatin
    75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity
  • Drug: Gefitinib
    250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity
  • Experimental: Pemetrexed/Cisplatin/Gefitinib
    Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Pemetrexed
    • Drug: Cisplatin
    • Drug: Gefitinib
  • Experimental: Pemetrexed/Cisplatin
    Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Pemetrexed
    • Drug: Cisplatin
Ahn MJ, Yang JC, Liang J, Kang JH, Xiu Q, Chen YM, Blair JM, Peng G, Linn C, Orlando M. Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 2012 Aug;77(2):346-52. doi: 10.1016/j.lungcan.2012.03.011. Epub 2012 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2010
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
  • Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
  • Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

  • Concurrent administration of any other tumor therapy
  • Other co-existing malignancies
  • Pregnancy or breast feeding
  • Serious concomitant disorders
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Taiwan
 
NCT00409006
10918, H3E-AA-S110
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2010

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