Re-induction of a systemic immune response after initial response with immune therapy with radiotherapy in metastatic or locally recurrent lung cancer

Phase 2

Completed

• Conditions: lung cancer; Non small cell; 10038666; 10029107

• Registration Number: NL-OMON50328
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Non small cell lung cancer
- CR, PR or SD initially under immune therapy (possibly combined with
chemotherapy)
- Progressive disease
- Able to continue the same immune therapy (i.e. no adverse events grade 3 or
more)

Exclusion Criteria

- Patients with any grade 3 or higher toxicity from previous therapy;
- Patients who are not eligible for continuation of the immune therapy
according to standard practice;
- Corticosteroids in a dose of at maximum 10mg prednisone or equivalent per
day.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate the progression-free survival after radiotherapy to a single<br /><br>lesion in patients with stage IV non-small cell lung cancer who achieved at<br /><br>least stable disease with immune therapy alone or concurrent immune therapy and<br /><br>chemotherapy and who show disease progression. The same immune therapy will be<br /><br>continued.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To investigate the remission rate (RECIST 1.1) of the irradiated lesion<br /><br>- To investigate the remission rate (RECIST 1.1) of the non-irradiated lesion(s)<br /><br>- To investigate the toxicity of this combination.<br /><br>- Biobanking for later translational research<br /><br>- Overall survival<br /><br>- Immune response to combined radio/immunotherapy (blood-based)</p><br>