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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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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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Enzastaurin/Pemetrexed/Carboplatin

Group Type EXPERIMENTAL

enzastaurin

Intervention Type DRUG

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

pemetrexed

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

Pemetrexed/Carboplatin

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

Docetaxel/Carboplatin

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

Interventions

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enzastaurin

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

Intervention Type DRUG

pemetrexed

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

Intervention Type DRUG

docetaxel

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

Intervention Type DRUG

carboplatin

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

Intervention Type DRUG

Other Intervention Names

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LY317615 LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* You must have been diagnosed with NSCLC.
* You must be able to visit the doctor's office weekly during the active treatment period and as needed during the study follow-up period.
* You must be willing and able to swallow capsules.
* Your entry labs and medical tests must meet study requirements.
* You must be willing to have blood samples drawn and tissue samples obtained for gene and protein testing.

Exclusion Criteria

* You have received radiation within 2 weeks of study enrollment.
* You have previously received any anti-cancer drug therapy for NSCLC.
* You have an active infection or other serious condition.
* You take aspirin or aspirin-like medication regularly and are not able to stop taking them for a few days during each cycle of chemotherapy.
* You have recently lost a significant amount of weight.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No