Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
immunotherapy, chemoradiotherapy, resection, PD-L1
Brief summary
In a certified lung- cancer center, patients with NSCLC and a potentially curative stage (including patients with oligometastatic disease) are prospectively enrolled if curative treatment (either definitive radio-chemotherapy or resection) cannot be performed due to large tumor size or for functional reasons. For these patients, the multidisciplinary tumor board (MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically including PET-CT if indicated. After review of the MDB, patients receive either definitive curative treatment or palliative treatment.
Detailed description
In a certified lung- cancer center, patients with NSCLC and a potentially curative stage (including patients with oligometastatic disease) are prospectively enrolled if curative treatment (either definitive radio-chemotherapy or resection) cannot be performed due to large tumor size or for functional reasons (e. g. too large radiation field or functionally inoperable for the required resection). For these patients, the multidisciplinary tumor board (MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically including PET-CT if indicated. After review of the MDB, patients receive either definitive curative treatment or palliative treatment.
Interventions
induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy
Sponsors
Study design
Eligibility
Inclusion criteria
* newly diagnosed NSCLC * histologically or cytologically proven * stage III - IVA (oligometastatic) by complete staging * ECOG 0-2 * life expectancy 3 months * ability to provide written informed consent
Exclusion criteria
* primary resectability * primary definitive chemoradiotherapy feasible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patients completing definitive therapy | 1 year | proportion of patients completing definitive therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete or partial radiologic response | 1 year | proportion of patients who achieved complete or partial radiologic response |
| local downstaging | 1 year | proportion who achieved local downstaging |
| complete metabolic response | 1 year | proportion who achieved complete metabolic response |
| overall survival (OS) | 5 years | overall survival (OS) |
| event-free survival (EFS) | 5 years | event-free survival (EFS) |
Countries
Germany