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

• Sponsor: Klinikum Esslingen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04926584
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 120.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: induction therapy

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

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 15, 2017
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2027

Outcome Measures

Primary Outcome Measures

1. patients completing definitive therapy [1 year]

   proportion of patients completing definitive therapy

Secondary Outcome Measures

1. complete or partial radiologic response [1 year]

   proportion of patients who achieved complete or partial radiologic response

2. local downstaging [1 year]

   proportion who achieved local downstaging

3. complete metabolic response [1 year]

   proportion who achieved complete metabolic response

4. overall survival (OS) [5 years]

   overall survival (OS)

5. event-free survival (EFS) [5 years]

   event-free survival (EFS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Esslingen	Esslingen		Germany	73730

Sponsors and Collaborators

• Klinikum Esslingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Faehling, Head of Pneumology, Klinikum Esslingen
• ClinicalTrials.gov Identifier: NCT04926584
• Other Study ID Numbers: KOMPASSneo
• First Posted: Jun 15, 2021
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Martin Faehling, Head of Pneumology, Klinikum Esslingen: immunotherapy, chemoradiotherapy, resection, PD-L1
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 16, 2022