Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146)

Phase 2 Terminated 53 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).

Timeline

Start: 2008-03-04
Primary completion: 2011-01-06
Completion: 2011-01-07

Outcome

Missed primary endpoint

registry Temozolomide Treatment vs Observation; p = 0.6995; 2-sided Exact Pearson Chi-square Test NCT00632203 ↗

paper No difference was noted in the incidence of BM at 1 year in the TMZ and observation groups (18% and 13%, respectively) PMID 25069747 ↗

paper TMZ monotherapy does not appear to decrease the incidence of BM in patients with locally advanced NSCLC. PMID 25069747 ↗

Publications

Results Boggs DH, Robins HI, Langer CJ, Traynor AM, Berkowitz MJ, Mehta MP. Strategies to prevent brain metastasis in high-risk non-small-cell lung cancer: lessons learned from a randomized study of maintenance temozolomide versus observation. Clin Lung Cancer. 2014 Nov;15(6):433-40. doi: 10.1016/j.cllc.2014.06.008. Epub 2014 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temozolomide	Small molecule	75 mg/m2	Oral