Description
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.
Scope & Applicability
Product Classes
2Guidance for industry regarding clinical trial endpoints for approval; Clinical trial endpoints for the approval of NSCLC drugs and biologics; Endpoints for the approval of NSCLC drugs
Products for which batch/lot information is particularly important
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
IRC response used in summary level data; Evaluator for response assessments separate from the investigator.
Regulatory Context
Attributes
6Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes
Incomplete or no baseline tumor assessments results in censoring at Randomization
Reasons for dropouts should be incorporated into procedures for determining censoring
reliability includes accuracy, completeness, and traceability
Estimate of the overall survival HR
Endpoints considered based on the population and risk-benefit profile
See Also (8)
- Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry (Status: Draft)
- Upper Facial Lines: Developing Botulinum Toxin Drug Products (Status: Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry (Status: Final)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)
- Vaginal Microbicides:Development for the Prevention of HIV Infection PDF (Status: Final)
- Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (Status: Final)
- Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry (Status: Draft)