Tailored Second Line Treatment by Epidermal Growth Factor Receptor (EGFR) Mutation in Patients With Advanced Lung Adenocarcinoma

Sponsor
National Cheng-Kung University Hospital
Study ID
NCT00903292
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • erlotinib (Tarceva) — DRUG
    chemotherapy with erlotinib
  • pemetrexed (Alimta) — DRUG
    Chemotherapy with pemetrexed

Study Details

Currently the investigators have two different classes of second-line treatment options in recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction in overall survival and progression free survival that indicated better efficacy for non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.

Key Dates

First listed
May 18, 2009
Start date
Mar 31, 2009
Status verified
May 2009
Primary completion
Apr 30, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
52 participants (estimated)
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: A, erlotinib
    If EGFR mutation found then assigned to thyrosine kinase inhibitor (erlotinib)
  • Active Comparator: B, pemetrexed
    If EGFR wild type found then assigned to chemotherapy (pemetrexed)

Primary Outcome Measure

The primary analysis will be the overall best response rate, including a 95% confidence interval (Leemis and Trivedi 1996). [ Time Frame: 02/2009 - 04/2010 ]

Central Contacts

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