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First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00308750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2021-05-13

Study results available
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Summary

The purposes of this study are to determine:

The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.

Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer, compared with the combination of docetaxel and carboplatin.

Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.

The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.

The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.

The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about NSCLC and how enzastaurin works in the body.

Conditions

Interventions

DRUG

enzastaurin

1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression

DRUG

pemetrexed

500 milligrams per square meter (mg/m\^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease

DRUG

docetaxel

75 mg/m\^2, IV, q 21 days, six 21 day cycles or progressive disease

DRUG

carboplatin

Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00308750 on ClinicalTrials.gov