Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: induction therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: induction therapy|induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients completing definitive therapy | proportion of patients completing definitive therapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete or partial radiologic response | proportion of patients who achieved complete or partial radiologic response | 1 year | 
| local downstaging | proportion who achieved local downstaging | 1 year | 
| complete metabolic response | proportion who achieved complete metabolic response | 1 year | 
| overall survival (OS) | overall survival (OS) | 5 years | 
| event-free survival (EFS) | event-free survival (EFS) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, chemoradiotherapy, resection, PD-L1