To evaluate the efficacy/safety of osimertinib prior to CRT and maintenance of it with Stage III, unresectable NSCLC with EGFR mutations - NEOLA

Study identifier:D516AC00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients with Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)

Medical condition

lung cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Osimertinib, Cisplatin or Carboplatin; Pemetrexed or Paclitaxel, Radiation

Sex

All

Estimated Enrollment

70

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Mar 2024
Estimated Primary Completion Date: 01 Mar 2027
Estimated Study Completion Date: 01 Mar 2028

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria