A082402/NRG-LU010

A082402/NRG-LU010: Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy [I²-Port] For Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy [Ypn2].

Principal Investigator

Salma Jabbour, MD, PhD

Status

Disease Site

Lung [LU] Other

Phase

II

Developmental Therapeutics

Yes

Primary Objective

I.   To assess whether intensity-modulated post-operative radiation therapy (I²-PORT) improves disease-free survival (DFS) of patients with R0 resected ypN2 NSCLC compared to standard of care (SOC).

II.  To assess whether I²-PORT does not unacceptably increase (by ≥ 6.5 percentage points) the rate of severe (grade ≥ 3 per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5) late cardiopulmonary toxicity compared to SOC.

 

NOTE:

This is a joint Alliance and NRG Oncology trial. NRG Oncology institutions can credit NRG for their case accrual.

Alliance PI: David Kozono, MD, PhD

 

Patient Population

Patient Population: Patients with a histopathologic diagnosis of non small cell lung cancer, who may have mixed or multiple histologies but no small cell component.

Target Accrual

164