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NCT Number: NCT04926584

Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

Location status: Recruiting

Location contact

Annika Landmesser

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induction therapy

Drug

induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy

Primary outcomes

  1. patients completing definitive therapy

    Time frame: 1 year

    proportion of patients completing definitive therapy

Secondary outcomes

  1. complete or partial radiologic response

    Time frame: 1 year

    proportion of patients who achieved complete or partial radiologic response

  2. local downstaging

    Time frame: 1 year

    proportion who achieved local downstaging

  3. complete metabolic response

    Time frame: 1 year

    proportion who achieved complete metabolic response

  4. overall survival (OS)

    Time frame: 5 years

    overall survival (OS)

  5. event-free survival (EFS)

    Time frame: 5 years

    event-free survival (EFS)

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Faehling, MD, MSc

CONTACT

[email protected]

+49711310382411

Sponsors and collaborators

Lead sponsor

Klinikum Esslingen

Other

Registry information

Official study 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

Acronym: KOMPASSneo

Important dates

Study start
2017
Primary completion
2024
Study completion
2027
First posted
Jun 15, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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