Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Sponsor
Si-Yu Wang
Study ID
NCT01565538
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    150 mg Given orally
  • Pemetrexed — DRUG
    500mg/m2 Given IV

Study Details

Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Key Dates

First listed
Mar 28, 2012
Start date
Dec 31, 2008
Status verified
Sep 2014
Primary completion
May 31, 2012
Completion
May 31, 2013

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib at the dose of 150 mg orally once a day continually until progression.
  • Experimental: Pemetrexed
    Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Primary Outcome Measure

Progression-Free Survival [ Time Frame: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization. ]

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