First Line Chemotherapy Treatment of Advanced NSCLC

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: enzastaurin (Drug); pemetrexed (Drug); docetaxel (Drug); carboplatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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 patients with non-small cell lung cancer 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 non-small cell lung cancer and how enzastaurin works in the body.

Official title: A Randomized, Open-Label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to progressive disease

Secondary outcome:

Assessment of biomarkers relevant to pemetrexed, carboplatin, enzastaurin, and disease state, and their correlation to clinical outcome

Assessment of smoking history and hormone replacement therapy and the correlation to clinical outcome

Comparisons of safety between each treatment arm

Comparisons of patient reported outcomes using the FACT-Lung and FACT-Taxane

Overall survival

Duration of response

Time to treatment failure

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- You must have been diagnosed with non-small cell lung cancer.

- 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 non-small cell lung

cancer.

- 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.

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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., Burlington, North Carolina 27215, United States; Recruiting
Eli Lilly

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., Chapel Hill, North Carolina 27599, United States; Recruiting
Eli Lilly

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., Columbia, South Carolina 29210, United States; Recruiting
Eli Lilly

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., Houston, Texas 77060, United States; Recruiting
Eli Lilly

Starting date: March 2006
Ending date: August 2008
Last updated: December 21, 2007