Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option
KOMPASSneo
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
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedAugust 16, 2022
August 1, 2022
7 years
June 9, 2021
August 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patients completing definitive therapy
proportion of patients completing definitive therapy
1 year
Secondary Outcomes (5)
complete or partial radiologic response
1 year
local downstaging
1 year
complete metabolic response
1 year
overall survival (OS)
5 years
event-free survival (EFS)
5 years
Interventions
induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- primary resectability
- primary definitive chemoradiotherapy feasible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pneumology
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 15, 2021
Study Start
December 15, 2017
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2027
Last Updated
August 16, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share