A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-Small-Cell Lung Cancer
Trial Information
A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer
Inclusion Criteria:
- Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
- Patients must be non-smokers
- Patients must have at least one measurable lesion
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
- Patients must have failed only one prior chemotherapy regimen and must be considered
eligible for further chemotherapy following progression of their disease.
Exclusion Criteria:
- Patients who have received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication
- Patients who have previously received treatment with drugs against the human
epidermal growth factor receptors
- Patients who have previously received treatment with drugs which have similar targets
as Pemetrexed
- Patients who have any known significant ophthalmologic abnormalities of the surface
of the eye
- Patients who have a history of severe hypersensitivity reaction to erlotinib or
pemetrexed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival (PFS)
Outcome Description:
PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.
Outcome Time Frame:
Randomization to measured PD up to 38 months
Safety Issue:
No
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
10725
NCT ID:
NCT00550173
Start Date:
November 2007
Completion Date:
January 2012
Related Keywords:
- Non-Small-Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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