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

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.

Timeline

Start

2006-03

Primary completion

2009-07

Completion

2009-07

Outcome

Missed primary endpoint

paper CONCLUSION: There was no difference in TTP between the three arms, but survival was longer with pemetrexed-carboplatin compared with docetaxel-carboplatin. PMID 21102260 ↗

registry analysis (unspecified test); Enzastaurin/Pemetrexed/Carboplatin vs Docetaxel/Carboplatin; p = 0.40; Log Rank NCT00308750 ↗

registry analysis (unspecified test); Pemetrexed/Carboplatin vs Docetaxel/Carboplatin; p = 0.19; Log Rank NCT00308750 ↗

Publications

• Socinski MA, Raju RN, Stinchcombe T, Kocs DM, Couch LS, Barrera D, Rousey SR, Choksi JK, Jotte R, Patt DA, Periman PO, Schlossberg HR, Weissman CH, Wang Y, Asmar L, Pritchard S, Bromund J, Peng G, Treat J, Obasaju CK. Randomized, phase II trial of pemetrexed and carboplatin with or without enzastaurin versus docetaxel and carboplatin as first-line treatment of patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1963-9. doi: 10.1097/JTO.0b013e3181fd42eb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Subject	enzastaurin	Small molecule	500 mg	Oral
Background	Carboplatin	Small molecule	—	Intravenous

Indications