Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy

Phase 2 Completed 60 enrolled Yonsei University

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and RRM1 of the tumor cells.

Timeline

Start: 2012-07-27
Primary completion: 2015-06-30
Completion: 2015-06-30

Outcome

Missed primary endpoint

paper The median PFS was 5.2 months in the experimental arm and 5.4 months in the control arm (P = 0.286). PMID 26811178 ↗

paper CONCLUSION: ERCC1 and RRM1 mRNA expression-based chemotherapy did not improve clinical outcomes in advanced NSCLC (NCT01648517). PMID 26811178 ↗

Publications

Heo SJ, Jung I, Lee CK, Kim JH, Lim SM, Moon YW, Shim HS, Jeong J, Kim JH, Kim HR, Cho BC. A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2016 Mar;77(3):539-48. doi: 10.1007/s00280-016-2968-z. Epub 2016 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Vinorelbine	Small molecule	20 mg/m2	—
Subject	Vinorelbine	Small molecule	25 mg/m2	—