Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

Phase 3 Completed 939 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).

Timeline

Start: 2005-01
Primary completion: 2011-07
Completion: 2011-07

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Cetuximab & Pemetrexed vs Pemetrexed; p = 0.756; Hazard Ratio (HR) 1.03 (95% CI 0.87 to 1.21); NCT00095199 ↗

paper Median progression-free survival with cetuximab plus pemetrexed was 2·9 months (95% CI 2·7-3·2) versus 2·8 months (2·5-3·3) with pemetrexed (HR 1·03, 95% CI 0·87-1·21; p=0·76). PMID 24231627 ↗

Publications

Kim ES, Neubauer M, Cohn A, Schwartzberg L, Garbo L, Caton J, Robert F, Reynolds C, Katz T, Chittoor S, Simms L, Saxman S. Docetaxel or pemetrexed with or without cetuximab in recurrent or progressive non-small-cell lung cancer after platinum-based therapy: a phase 3, open-label, randomised trial. Lancet Oncol. 2013 Dec;14(13):1326-36. doi: 10.1016/S1470-2045(13)70473-X. Epub 2013 Nov 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous