NCT03237377

Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-12
• Primary completion: 2021-11-04
• Completion: 2024-05-23
• First posted: 2017-08-02
• Last updated: 2025-10-14
• Results posted: 2023-10-16

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study