A Phase II, Single-Arm Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer who have not Progressed after Platinum-Based Concurrent Chemoradiation - MO43156

F. Hoffmann-La Roche AG0 sites130 target enrollmentJanuary 11, 2024

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Ability to comply with the study protocol, including willingness to remain in the post\-treatment period, 2\. Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non\-squamous histology, 3\. Whole\-body positron emission tomography–computed tomography (PET\-CT) scan (from the base of skull to mid\-thighs) for the purposes of staging, performed prior and within 42 days of the first dose of cCRT, 4\. At least two prior cycles of platinum\-based chemotherapy administered concurrently with radiotherapy (cCRT) completed within 1 to 42 days prior to baseline (one cycle of cCRT is defined as 21 or 28 days), 5\. The radiotherapy (RT) component in the cCRT must have been at a total radiation dose of 60 (± 10%) Gy (54 Gy to 66 Gy), administered either as IMRT (preferred) or by 3D\-conforming technique., 6\. A known Programmed Cell Death 1–Ligand 1 (PD\-L1\) result, as determined by the investigational Ventana PD\-L1 (SP263\) CDx Assay and documented by means of central testing of a representative tumor tissue sample, in either a previously obtained archival tumor tissue sample or a fresh tissue sample obtained from a biopsy collected prior to the first dose of cCRT

•1\. Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease), 2\. NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene, 3\. Any evidence of Stage IV disease, 4\. Any Grade \= 2 unresolved toxicity and Grade \= 2 pneumonitis from previous cCRT, 5\. Treatment with sequential CRT for locally advanced NSCLC, 6\. Patients with locally advanced NSCLC who have progressed during or after definitive cCRT prior to baseline