Carcinoma, Non-Small-Cell Lung Clinical Trial
— KOMPASSneoOfficial title:
Prospective Trial of Immunotherapy Prior to Resection, Definitive Chemo-radiotherapy, or Palliative Therapy in Patients With Locally Advanced or Oligometastatic Non-small Cell Lung Cancer Without a Primary Curative Option
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Esslingen | Esslingen |
Lead Sponsor | Collaborator |
---|---|
Klinikum Esslingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | patients completing definitive therapy | proportion of patients completing definitive therapy | 1 year | |
Secondary | complete or partial radiologic response | proportion of patients who achieved complete or partial radiologic response | 1 year | |
Secondary | local downstaging | proportion who achieved local downstaging | 1 year | |
Secondary | complete metabolic response | proportion who achieved complete metabolic response | 1 year | |
Secondary | overall survival (OS) | overall survival (OS) | 5 years | |
Secondary | event-free survival (EFS) | event-free survival (EFS) | 5 years |
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