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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: pemetrexed; Drug: carboplatin; Drug: docetaxel; Drug: enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308750

10651

H6Q-US-S004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 3 patient groups

Enzastaurin/Pemetrexed/Carboplatin

Experimental group

Treatment:

Drug: pemetrexed

Drug: carboplatin

Drug: enzastaurin

Pemetrexed/Carboplatin

Experimental group

Treatment:

Drug: pemetrexed

Drug: carboplatin

Docetaxel/Carboplatin

Active Comparator group

Treatment:

Drug: carboplatin

Drug: docetaxel