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

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT04926584
• Lead Sponsor: Klinikum Esslingen

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.

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patients completing definitive therapy	1 year	proportion of patients completing definitive therapy

Secondary Outcome Measures

Name	Time	Method
local downstaging	1 year	proportion who achieved local downstaging
complete or partial radiologic response	1 year	proportion of patients who achieved complete or partial radiologic response
complete metabolic response	1 year	proportion who achieved complete metabolic response
overall survival (OS)	5 years	overall survival (OS)
event-free survival (EFS)	5 years	event-free survival (EFS)

Trial Locations

Locations (1)

Klinikum Esslingen; 🇩🇪 Esslingen, Germany