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TERMINATED
NCT03237377
PHASE2

Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.

Official title: Neoadjuvant Immunoradiation for Stage III Resectable Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2017-12-12

Completion Date

2024-05-23

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

1500mg via IV infusion every 4 weeks for up to 3 doses/cycles

DRUG

Tremelimumab

75mg via IV infusion every 4 weeks

RADIATION

Thoracic Radiation

5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction

PROCEDURE

lobectomy

patients may proceed to surgery post drug and radiation intervention for lung lobectomy

DRUG

Standard of care adjuvant chemotherapy

patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery

Locations (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada