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A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC


Phase 2
18 Years
N/A
Not Enrolling
Both
Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

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Trial Information

A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC


Inclusion Criteria:



- Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is
of nonsquamous histology and not amenable to curative therapy.

- Failure of previous treatment with one prior platinum-based chemotherapy regimen.

- Good performance status.

- Adequate bone marrow reserve, renal and hepatic functions.

Exclusion Criteria:

- Serious concomitant systemic disease.

- Inability to take oral medication.

- Inability or unwillingness to take vitamin supplementation and corticosteroids.

- Pregnancy / Breast-feeding.

- Treatment with certain medicines that prevent blood from clotting.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.

Outcome Time Frame:

Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 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:

Austria: Agency for Health and Food Safety

Study ID:

10721

NCT ID:

NCT00447057

Start Date:

March 2007

Completion Date:

June 2011

Related Keywords:

  • Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
  • nonsquamous
  • Carcinoma, Non-Small-Cell Lung

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