Response and Toxicity Prediction by Microbiome analysis in locally advanced NSCLC treated with IO (durvalumab) after Chemoradiotherapy (sequential and concurrent)

Recruiting

• Conditions: microbioma; Non small cell lung carcinoma; 10038666

• Registration Number: NL-OMON50946
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Stages IIIA, IIIB and IIIC (as per UICC 8th TNM edition) NSCLC
(histologically or cytologically confirmed) amenable for concurrent
chemoradiotherapy according to multidisciplinary tumor board.
2. No signs of disease progression after Chemoradiation (sequential and
concurrent)
3. At least 1 cycle of chemotherapy as part of the radiotherapy schedule but no
more chemotherapy between last radiotherapy session and start durvalumab
4. Absence of any of following targetable driver mutations: (EGFR, ALK, ROS1)
5. >= 18 years
6. ECOG <= 1
7. Must be willing to provide collected stool samples and allow to obtain a
throat swab during the observation period.
8. Demonstrate adequate organ function, all screening labs should be performed
within 10 days of start durvalumab

Exclusion Criteria

1. Is currently participating in or has participated in a study of an
investigational agent or using an investigational device within 4 weeks of the
first dose of treatment.
2. Has had prior monoclonal antibody therapy within 4 weeks prior to study Day
1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events
due to agents administered more than 4 weeks earlier.
3. Previous treatment with PD-1-PD-L1 axis inhibiting immunotherapy.
4. Active or history of autoimmune disease or immune deficiency,
5. Subjects with a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications within 14 days of study drug administration
6. Has evidence of symptomatic interstitial lung disease or an active,
non-infectious pneumonitis.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified