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Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00447057

Last Updated: 2011-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-06-30

Brief Summary

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This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Detailed Description

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Conditions

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Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pemetrexed (Nonsquamous)

Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity

Pemetrexed + Erlotinib (Nonsquamous)

Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Pemetrexed

Intervention Type DRUG

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Pemetrexed (Squamous)

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Pemetrexed + Erlotinib (Squamous)

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Erlotinib

Intervention Type DRUG

150 mg given po, QD, starting on the first day of the first cycle

Interventions

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Pemetrexed

500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity

Intervention Type DRUG

Erlotinib

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Intervention Type DRUG

Pemetrexed

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Intervention Type DRUG

Erlotinib

150 mg given po, QD, starting on the first day of the first cycle

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta Tarceva LY231514 Alimta Tarceva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Salzburg, , Austria

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Vienna, , Austria

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bochum, , Germany

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Freiburg im Breisgau, , Germany

Site Status

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Gauting, , Germany

Site Status

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Gerlingen, , Germany

Site Status

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Hamburg, , Germany

Site Status

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Hanover, , Germany

Site Status

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Immenhausen, , Germany

Site Status

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Trier, , Germany

Site Status

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Tübingen, , Germany

Site Status

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Ulm, , Germany

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deszk, , Hungary

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mátraháza, , Hungary

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nyíregyháza, , Hungary

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Székesfehérvár, , Hungary

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Alicante, , Spain

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Barcelona, , Spain

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madrid, , Spain

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Valencia, , Spain

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Linköping, , Sweden

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lund, , Sweden

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Solna, , Sweden

Site Status

Countries

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Austria Germany Hungary Spain Sweden

Other Identifiers

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H3E-MC-S102

Identifier Type: OTHER

Identifier Source: secondary_id

10721

Identifier Type: -

Identifier Source: org_study_id