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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04926584
Acronym
KOMPASSneo
Enrollment
50
Registered
2021-06-15
Start date
2017-12-15
Completion date
2027-12-31
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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

Klinikum Esslingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
patients completing definitive therapy1 yearproportion of patients completing definitive therapy

Secondary

MeasureTime frameDescription
complete or partial radiologic response1 yearproportion of patients who achieved complete or partial radiologic response
local downstaging1 yearproportion who achieved local downstaging
complete metabolic response1 yearproportion who achieved complete metabolic response
overall survival (OS)5 yearsoverall survival (OS)
event-free survival (EFS)5 yearsevent-free survival (EFS)

Countries

Germany

Contacts

Primary ContactMartin Faehling, MD, MSc
m.faehling@klinikum-esslingen.de+49711310382411

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026