Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC (AYAME)

AstraZeneca

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03995875

D4194R00013

Details and patient eligibility

About

This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.

Full description

Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.

Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test

Enrollment: 529 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
• Patients who provided written informed consent.

Exclusion criteria

• Patients who would join Post Marketing Surveyllance for durvalumab.
• Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment
• Age < 20