Issue Date: April 22, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics
The purpose of this guidance is to provide recommendations to applicants on endpoints for nonsmall cell lung cancer (NSCLC) clinical trials of drugs that are submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. This guidance is a companion to the guidance for industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.
Download the Guidance Document
