IASLC-FDA Lung Cancer Neoadjuvant Meeting 2018 (#LCN18)
GOAL AND PURPOSE:
This initial meeting between the FDA, the IASLC, industry and investigators is designed to facilitate discussions regarding the standardization of endpoints in neoadjuvant lung cancer trials and to discuss how said endpoints can be validated by comparing novel endpoints to established time to event endpoints.
- Investigators and sponsors developing neoadjuvant clinical trials in early lung cancer
- Patient advocates interested in lung cancer clinical trials
- Regulatory scientists
- Obtain standardized definitions of trial endpoints such as major pathologic response;
- Determine trial eligibility;
- Understand the current state of ongoing and planned trials; and
- Understand endpoints and designs that could ultimately lead to early supplemental drug approvals with confirmation of evidence.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
5701 Marinelli Road
Rockville, Maryland, 20852