Durvalumab vs placebo with stereotactic body radiation therapy in early stage unresected non-small cell lung cancer (NSCLC) patients / Osimertinib following SBRT in patients with early stage unresected NSCLC harboring an EGFR mutation - PACIFIC-4

Study identifier:D9103C00001

ClinicalTrials.gov identifier:NCT03833154

EudraCT identifier:2018-002572-41

CTIS identifier:N/A

Recruiting

Official Title

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib following SBRT, a single arm cohort for patients with unresected Stage I/II, lymph node negative NSCLC harboring a sensitizing EGFR mutation

Medical condition

Carcinoma, Non-Small-Cell Lung

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Osimertinib (single-arm, open-label)

Sex

All

Estimated Enrollment

690

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 06 Mar 2019
Estimated Primary Completion Date: 31 Mar 2026
Estimated Study Completion Date: 04 Apr 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria