Clinical trial NCT04926584: Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: immunotherapy, chemoradiotherapy, resection, PD-L1
Lead sponsor: Klinikum Esslingen
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or oligometastatic NSCLC (stage IIIA - IVA) wae elegible if curative treatment (either resection or chemoradiotherapy is not possible for anatomical or functional reasons

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.

Eligibility criteria: 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

Primary outcomes:
measure: patients completing definitive therapy
timeFrame: 1 year
Secondary outcomes:
measure: complete or partial radiologic response
timeFrame: 1 year
measure: local downstaging
timeFrame: 1 year
measure: complete metabolic response
timeFrame: 1 year
measure: overall survival (OS)
timeFrame: 5 years
measure: event-free survival (EFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Klinikum Esslingen
Study officials:
References: