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RecruitingNSCLC, Stage IIILocally Advanced Lung Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

2 states

Healthy volunteers

No

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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.

Sponsor: Jun Zhang, MD, PhD

You may qualify if…

  • ✓ 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)

You may not qualify if…

  • ✕ 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

Where it's recruiting

Kansas

Kansas City

Rhode Island

Providence

Source: ClinicalTrials.gov · NCT04680377 · last updated 2024-05-08

Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Ch · TrialPath