DDT COA #000133: Small Cell Lung Cancer PRO

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Oncologic Diseases (OOD)
Division of Oncology 2 (DO2)

DDT COA Number
DDT COA #000133

Instrument Name
Small cell lung cancer (SCLC) symptom measure

Disease/Condition
Small cell lung cancer

Concept of Interest
SCLC symptom severity

Context of Use
Adult patients (> 18 years) with clinician-confirmed diagnosis of limited or extensive stage SCLC with Eastern Cooperative Oncology Group performance status of 0 to 2 regardless of the lines of therapy being administered

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Critical Path Institute: Patient- Reported Outcome (PRO) Consortium, Small Cell Lung Cancer Working group

Contact(s)
Sonya Eremenco

Date Accepted into CDER’s COA Qualification Program
July 6, 2020

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	4/28/20	FDA Response (Accepted)	7/6/20