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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Klinikum Esslingen
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- patients completing definitive therapy
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Martin Faehling
Head of Pneumology
Klinikum Esslingen
Eligibility Criteria
Inclusion Criteria
- •newly diagnosed NSCLC
- •histologically or cytologically proven
- •stage III - IVA (oligometastatic) by complete staging
- •life expectancy 3 months
- •ability to provide written informed consent
Exclusion Criteria
- •primary resectability
- •primary definitive chemoradiotherapy feasible
Outcomes
Primary Outcomes
patients completing definitive therapy
Time Frame: 1 year
proportion of patients completing definitive therapy
Secondary Outcomes
- local downstaging(1 year)
- complete or partial radiologic response(1 year)
- complete metabolic response(1 year)
- overall survival (OS)(5 years)
- event-free survival (EFS)(5 years)