Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC

Summary

This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without consolidation chemotherapy. A total of 60 subjects will be enrolled to this study over a 4 year accrual period.

Timeline

Start

2017-05-12

Primary completion

2023-07-12

Completion

2027-07

Outcome

Missed primary endpoint

registry analysis (superiority test); SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy; p = .388; Rate 0.627 (95% CI 0.492 to 0.750); Fisher Exact NCT03141359 ↗

paper INTERPRETATION: Although this study did not meet the primary endpoint PMID 39615497 ↗

Publications

• Heinzerling JH, Mileham KF, Robinson MM, Symanowski JT, Induru RR, Brouse GM, Corso CD, Prabhu RS, Haggstrom DE, Moeller BJ, Bobo WE, Fasola CE, Thakkar VV, Pal SE, Gregory JM, Norek SL, Begic XJ, Kesarwala AH, Burri SH, Simone CB 2nd. Primary lung tumour stereotactic body radiotherapy followed by concurrent mediastinal chemoradiotherapy and adjuvant immunotherapy for locally advanced non-small-cell lung cancer: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):85-97. doi: 10.1016/S1470-2045(24)00573-4. Epub 2024 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	2 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	50 mg/m2	Intravenous
Subject	Durvalumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Etoposide	Small molecule	50 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	50 mg/m2	Intravenous

Indications