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A Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non−Small Cell Lung Cancer who have already received chemotherapy and radiotherapy
EU CTIS ID: 2023-503756-27-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kuwait
- Brazil
- Panama
- Costa Rica
- Vietnam
- China
- Saudi Arabia
- Chile
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuwait; Brazil; Panama; Costa Rica; Vietnam; China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.