Actively Recruiting
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
Led by Jun Zhang, MD, PhD · Updated on 2024-05-08
44
Participants Needed
2
Research Sites
294 weeks
Total Duration
On this page
Sponsors
J
Jun Zhang, MD, PhD
Lead Sponsor
R
Rhode Island Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity.
CONDITIONS
Official Title
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of participant or legally authorized representative to understand the study and willingness to sign informed consent
- Willingness and ability to comply with the protocol, including treatment and scheduled visits
- Life expectancy of at least 12 weeks
- Male or female aged 18 years or older
- Received two or more cycles of platinum-based chemotherapy concurrently with definitive radiation therapy (54-66 Gy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Body weight greater than 30 kg (66.14 lbs)
- Histologically- or cytologically-confirmed locally advanced, unresectable stage III NSCLC
- No disease progression after definitive platinum-based concurrent chemoradiation therapy
- Adequate organ function based on laboratory results
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use contraception or abstain from sexual activity during and for a specified time after the study
You will not qualify if you...
- Concurrent enrollment in another clinical study unless observational or in follow-up period
- Participation in a clinical study with investigational product within 4 weeks prior to enrollment
- Prior randomization or treatment in a durvalumab clinical study
- Mixed small cell and non-small cell lung cancer histology
- Receipt of sequential chemoradiation therapy for locally advanced NSCLC
- Disease progression during definitive platinum-based concurrent chemoradiation therapy
- Receipt of any investigational drug within 4 weeks prior to durvalumab or certain monoclonal antibodies within 6 weeks
- Prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 or other immunotherapy
- Receipt of live attenuated vaccine within 30 days prior to durvalumab
- Current or prior use of immunosuppressive medication within 14 days before durvalumab
- Unresolved toxicity grade 2 or higher from prior therapies except certain exceptions
- Any grade pneumonitis from previous chemoradiation
- Active infection
- Recent major surgery within 28 days prior to study therapy
- Active or prior autoimmune or inflammatory disorders
- History of primary immunodeficiency or other primary malignancy
- History of organ transplantation requiring immunosuppression
- History of leptomeningeal carcinomatosis
- Active ventricular arrhythmia requiring medication
- Uncontrolled illness
- Known allergy to durvalumab or its ingredients
- Psychiatric or social conditions limiting compliance or consent ability
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205
Actively Recruiting
2
Rhode Island Hospital, Brown University
Providence, Rhode Island, United States, 02905
Not Yet Recruiting
Research Team
K
KUCC Navigation
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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