Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

August 2, 2019

Primary Completion Date

October 30, 2021

Study Completion Date

March 9, 2022

Conditions
Non Small Cell Lung CancerStage III Non-small-cell Lung Cancer
Interventions
DEVICE

Durvalumab

"Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29~Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1"

DRUG

Paclitaxel

Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36

DRUG

Carboplatin

Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36

RADIATION

Radiation

1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).

PROCEDURE

Surgical Resection

Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.

Trial Locations (4)

10016

New York University Clinical Cancer Center, New York

46202

Indiana University Melvin and Bren Simon, Indianapolis

60612

Rush University Medical Center, Chicago

77030

MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Indiana University School of Medicine

OTHER

lead

Greg Durm, MD

OTHER