A Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non−Small Cell Lung Cancer who have already received chemotherapy and radiotherapy
Key facts
- Where
- Barcelona és Oviedo, SpanyolországSee the 2 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-503756-27-00
- Record updated
- 2025. október 23.
- Original description
1. To evaluate the efficacy of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after at least two cycles of platinum-based concurrent chemoradiation therapy (cCRT) based on 12-month progression-free survival (PFS) rateRead full original descriptionShow less
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
1. To evaluate the efficacy of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after at least two cycles of platinum-based concurrent chemoradiation therapy (cCRT) based on 12-month progression-free survival (PFS) rate
Inclusion: Ability to comply with the study protocol, including willingness to remain in the post-treatment period; Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology; 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; 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); 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; 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.
Exclusion: Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease); Any Grade ≥ 2 unresolved toxicity and Grade ≥ 2 pneumonitis from previous cCRT; Treatment with sequential CRT for locally advanced NSCLC; Patients with locally advanced NSCLC who have progressed during or after definitive cCRT prior to baseline; Any evidence of Stage IV disease; NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene.