drugset / Trial / NCT01928160

Pemetrexed Disodium and Carboplatin or Cisplatin With or Without Erlotinib Hydrochloride in Treating Patient With Stage IV Non-Small Cell Lung Cancer Resistant to First-Line Therapy With Erlotinib Hydrochloride or Gefitinib

NCT01928160 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well pemetrexed disodium and carboplatin or cisplatin with or without erlotinib hydrochloride work in treating patients with epidermal growth factor receptor (EGFR) mutant positive stage IV non-small cell lung cancer and acquired resistance to first-line therapy with erlotinib hydrochloride or gefitinib. In patients that develop resistance to first-line therapy with EGFR tyrosine kinase inhibitors (TKIs) the drug is usually stopped and the patient is switched to chemotherapy. Drugs used in chemotherapy, such as pemetrexed disodium, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium and carboplatin or cisplatin is more effective with or without erlotinib hydrochloride in treating patients with EGFR mutant non-small cell lung cancer and acquired resistance to EGFR TKIs.

Timeline

Start
2014-06
Primary completion
2015-03
Completion
2015-03

Outcome

Outcome not reported

Stopped (Enrollment): “study not accruing”

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule — Oral
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified — Intravenous
Background Pemetrexed Small molecule — Intravenous