Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

NCT ID: NCT00520676

Last Updated: 2011-08-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pemetrexed plus carboplatin

Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum

Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

500 mg/m\^2, IV, q 21 days x 6 cycles maximum

carboplatin

Intervention Type DRUG

AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

docetaxel plus carboplatin

Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum

Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

75 mg/m\^2, IV, q 21 days x 6 cycles maximum

carboplatin

Intervention Type DRUG

AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

Interventions

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pemetrexed

500 mg/m\^2, IV, q 21 days x 6 cycles maximum

Intervention Type DRUG

docetaxel

75 mg/m\^2, IV, q 21 days x 6 cycles maximum

Intervention Type DRUG

carboplatin

AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
* Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
* Estimated life expectancy of at least 8 weeks

Exclusion Criteria

* Known or suspected brain metastases
* Concurrent administration of any other tumor therapy
* Serious concomitant disorders
* Pregnancy or breast feeding
* Inability or unwillingness to take folic acid or vitamin B12 supplementation
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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Eli Lilly and Company

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.

Ballarat, Victoria, Australia

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.

Frankston, Victoria, Australia

Site Status

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Wendouree, Victoria, Australia

Site Status

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Bunbury, Western Australia, Australia

Site Status

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Barretos, , Brazil

Site Status

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Goiânia, , Brazil

Site Status

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Santo André, , Brazil

Site Status

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São Paulo, , Brazil

Site Status

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Beijing, , China

Site Status

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Nanjing, , China

Site Status

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Shanghai, , China

Site Status

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Ciudad Obregón, , Mexico

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.

Durango, , Mexico

Site Status

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Mexicali, , Mexico

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.

Mexico City, , Mexico

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.

Seoul, , South Korea

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.

Suwon, , South Korea

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.

Ulsan, , South Korea

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.

Taichung, , Taiwan

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.

Taoyuan District, , Taiwan

Site Status

Countries

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Australia Brazil China Mexico South Korea Taiwan

References

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Loureiro H, Kolben TM, Kiermaier A, Ruttinger D, Ahmidi N, Becker T, Bauer-Mehren A. Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials. JCO Clin Cancer Inform. 2023 Sep;7:e2300062. doi: 10.1200/CCI.23.00062.

Reference Type DERIVED
PMID: 37922432 (View on PubMed)

Pereira JR, Cheng R, Orlando M, Kim JH, Barraclough H. Elderly subset analysis of randomized phase III study comparing pemetrexed plus carboplatin with docetaxel plus carboplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. Drugs R D. 2013 Dec;13(4):289-96. doi: 10.1007/s40268-013-0032-6.

Reference Type DERIVED
PMID: 24277116 (View on PubMed)

Other Identifiers

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H3E-CR-S380

Identifier Type: OTHER

Identifier Source: secondary_id

11626

Identifier Type: -

Identifier Source: org_study_id

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