Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics: Guidance for Industry.

摘要

The purpose of this guidance is to provide recommendations to applicants on endpoints for non-small 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. This guidance addresses the FDA’s current thinking regarding efficacy endpoints in trials to evaluate drugs to treat lung cancer and takes into account discussions held at a public workshop (April 15, 2003) and at a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) (December 16, 2003).4 This guidance does not address efficacy endpoints for drugs intended to prevent or decrease the incidence of lung cancer.