drugset / Trial / NCT01565538

Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

NCT01565538 ↗

Phase 2 Completed 123 enrolled Si-Yu Wang
RandomizedParallel-groupOpen-labelTreatment

Summary

Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Timeline

Start
2008-12
Primary completion
2012-05
Completion
2013-05

Outcome

Missed primary endpoint

paper The difference in PFS between the 2 treatment groups was not significant (hazard ratio, 0.92; 95% CI, 0.62-1.37 [P= .683]). PMID 24481719 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications