RecruitingPhase not listed

Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients

Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up * Life expectancy ≥12 weeks * Males and females age ≥ 18 years * Allowable type and amount of prior therapy: Participants must have received two or more cycles of platinum-based chemotherapy (containing etoposide, vinblastine, vinorelbine, a taxane \[paclitaxel or docetaxel\], or pemetrexed) concurrently with definitive radiation therapy (54-66 Gy) * Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1 * Body weight \>30 kg (66.14 lbs) * Participants must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease * Participants must have not progressed following 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 practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for the time specified following completion of therapy Exclusion Criteria: * Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study * Participation in another clinical study with an investigational product during the last 4 weeks prior to enrollment on this study * Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment * Mixed small cell and non-small cell lung cancer histology * Participants who receive sequential chemoradiation therapy for locally advanced NSCLC * Participants with locally advanced NSCLC who have progressed whilst definitive platinum based, concurrent chemoradiation therapy * Receipt of any investigational drug within 4 weeks prior to the first dose of durvalumab; and in the case of monoclonal antibodies (not immunotherapy) 6 weeks prior to the first dose of durvalumab * Participants who have received prior anti-programmed death (PD)-1, anti- programmed death ligand (PD-L)1 or anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4 * Participants who have received prior immunotherapy * Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Participants, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of IP * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab * Any unresolved toxicity CTCAE ≥ Grade 2 from the prior chemoradiation / anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria * Any grade pneumonitis from prior chemoradiation therapy * Active infection * Recent major surgery within 28 days prior to the first dose of study therapy * Active or prior documented autoimmune or inflammatory disorders * History of primary immunodeficiency * History of another primary malignancy * History of allogenic organ transplantation/organ transplant that requires therapeutic immunosuppression * History of leptomeningeal carcinomatosis * Participants with active ventricular arrhythmia requiring medication * Uncontrolled intercurrent illness * Participants who have progressed following definitive, platinum-based, concurrent chemoradiation therapy * Known allergy or hypersensitivity to durvalumab or any of durvalumab's excipients * Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent

Study sites (2)

KS

RI