Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together.
Umang Swami, Yousef Zakharia, Jun Zhang
https://pubmed.ncbi.nlm.nih.gov/29781826Actively Recruiting
Age: 18Years +
All Genders
ID04680377
Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)
Led by Jun Zhang, MD, PhD · Updated on 2024-05-08
44
Participants Needed
2
Research Sites
52 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
Researchers are evaluating whether examining the microbiome in people with stage III non-small cell lung cancer (NSCLC) who will receive the drug durvalumab after chemoradiation can help predict treatment side effects. This observational phase IV study aims to understand how the bacteria present in the body might relate to adverse reactions during durvalumab therapy. Before starting durvalumab treatment, participants will provide samples from three different sources to analyze their microbiome bacteria. The study will monitor participants receiving standard durvalumab care, tracking changes in their microbiome and bacterial metabolic pathways over up to 18 months, along with any severe side effects. Additional measures include time to treatment interruption due to adverse events and progression-free survival tracked up to 36 months. Participants will undergo regular visits and assessments, including collection of microbiome samples and monitoring of side effects and disease progression. Researchers will evaluate the occurrence of serious adverse events, microbiome changes, and treatment outcomes while participants remain under standard care. The study duration allows long-term observation of microbiome dynamics and treatment safety in this patient group.
CONDITIONS
Brief Title
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative must understand the study and sign informed consent
- Willing and able to follow the study 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 with concurrent 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 following definitive platinum-based concurrent chemoradiation therapy
- Adequate organ function based on lab results
- Women of child-bearing potential and men with partners must agree to use contraception or abstinence during and after study participation
You will not qualify if you...
- Enrolled in another clinical study unless observational or in follow-up of interventional study
- Participation in another investigational product study within 4 weeks before this study
- Prior participation in a durvalumab clinical trial
- Mixed small cell and non-small cell lung cancer
- Sequential chemoradiation therapy for locally advanced NSCLC
- Disease progression after platinum-based concurrent chemoradiation therapy
- Use of investigational drugs within 4 weeks before durvalumab (6 weeks for monoclonal antibodies)
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies
- Receipt of live attenuated vaccine within 30 days before first dose
- Use of immunosuppressive medication within 14 days before first dose
- Unresolved toxicities grade 2 or higher from prior therapy except alopecia, vitiligo, and certain lab values
- Any grade pneumonitis from prior chemoradiation
- Active infection or recent major surgery within 28 days
- Active or prior autoimmune or inflammatory disorders
- History of primary immunodeficiency
- History of other primary malignancies
- History of organ transplant requiring immunosuppression
- History of leptomeningeal carcinomatosis
- Active ventricular arrhythmia requiring medication
- Uncontrolled illness
- Allergy or hypersensitivity to durvalumab or its ingredients
- Psychiatric or social issues limiting study compliance or informed consent ability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 18 months
Participants who receive standard of care durvalumab are observed with microbiome samples taken prior to treatment to help predict toxicity and with ongoing assessments up to 18 months.
Multiple visits for sample collection and assessments during treatment and follow-up
Long-term Monitoring
Duration - Up to 36 months
Participants are followed for progression-free survival outcomes for up to 36 months from study start.
Periodic visits depending on clinical follow-up
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
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Research Team
K
KUCC Navigation
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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Published Research Related To This Trial
Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy.
Christopher Strouse, Ashutosh Mangalam, Jun Zhang
https://pubmed.ncbi.nlm.nih.gov/30183502