U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
  1. Development & Approval Process | Drugs

DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

Qualified Clinical Outcome Assessments (COA)
Office of Oncologic Diseases (OOD)
Division of Oncology 2 (DO 2)

DDT COA Number
DDT COA #000009

Instrument Name
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

Disease/Condition
Non-Small Cell Lung Cancer (NSCLC)

Concept of Interest
Symptom severity (cough, pain, dyspnea, fatigue, and appetite)

Context of Use
Adult patients (> 18 years) with Stage IIIB or IV NSCLC that are:

  • Treatment naïve (i.e., treatment naïve to current chemotherapy and not having received chemotherapy for the past 6 months from study enrollment)
  • Treated (i.e., received chemotherapy in the last 6 months and recovered from any prior treatment related toxicities/adverse events to CTCAE v4.03 grade 1 or better)

COA Type
PRO

Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium

Contact(s)
Stephen Coons

Date Accepted into CDER's COA Qualification Program
July 27, 2011

Qualification Date
April 4, 2018
Qualification Statement

Qualification Supporting Information
Review

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Full Qualification Package 3/31/17 FDA Response (Qualified) 4/4/18

Back to Qualified Clinical Outcome Assessments (COA)

Back to Top