Carcinoma, Non-Small-Cell LungKOMPASSneoNCT04926584
Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option
An observational study of Carcinoma, Non-Small-Cell Lung, run by Klinikum Esslingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- induction therapy
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- primary resectability
- primary definitive chemoradiotherapy feasible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Esslingen
Esslingen am Neckar, 73730
Annika Landmesser, studienbuero@klinikum-esslingen.de
About this study
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
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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- induction therapy
- Keywords
- immunotherapy, chemoradiotherapy, resection, PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction therapyDrug
induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
patients completing definitive therapy
proportion of patients completing definitive therapy
Measured: 1 year
Secondary outcomes (5)
complete or partial radiologic response
proportion of patients who achieved complete or partial radiologic response
Measured: 1 year
local downstaging
proportion who achieved local downstaging
Measured: 1 year
complete metabolic response
proportion who achieved complete metabolic response
Measured: 1 year
overall survival (OS)
overall survival (OS)
Measured: 5 years
event-free survival (EFS)
event-free survival (EFS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start15 Dec 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Esslingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Faehling, Klinikum Esslingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926584
- Sponsor's protocol ID
- KOMPASSneo
- Acronym
- KOMPASSneo
- Status last verified
- Aug 2022
- First submitted
- 9 Jun 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04926584
- Acronym / sponsor ID
- KOMPASSneo / KOMPASSneo
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- immunotherapy, chemoradiotherapy, resection, PD-L1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Klinikum EsslingenUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- newly diagnosed NSCLC
- histologically or cytologically proven
- stage III - IVA (oligometastatic) by complete staging
- ECOG 0-2
- life expectancy 3 months
Key exclusion criteria (2 listed)
- primary resectability
- primary definitive chemoradiotherapy feasible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induction therapyinduction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy | Drug | – |
Primary outcome
patients completing definitive therapy
Time frame: 1 year
proportion of patients completing definitive therapy
5 secondary outcomes
complete or partial radiologic response
Time frame: 1 year
local downstaging
Time frame: 1 year
complete metabolic response
Time frame: 1 year
overall survival (OS)
Time frame: 5 years
event-free survival (EFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Klinikum Esslingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Faehling, MD, MSc (+49711310382411, m.faehling@klinikum-esslingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients completing definitive therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.