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NCT05669846 · ClinicalTrials.gov registry record · Phase 2
Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Diwakar Davar.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05669846: Recruiting Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Diwakar Davar.
NCT05669846 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Diwakar Davar. The registered enrollment target is 26 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05669846, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Diwakar Davar.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is to determine if Healthy Donor FMT (hdFMT) improves the body's ability to fight cancer in patients with relapsed/refractory PD-L1 Positive NSCLC.
Primary Outcome
The proportion of patients with objective response (Complete Response (CR) or Partial Response (PR)) to R-FMT and pembrolizumab treatment in PD-1 primary refractory NSCLC as assessed per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Healthy Donor Fecal Microbiota Transplant (hdFMT)
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2025-01-08 |
| Est. Completion | 2036-12-31 |
| Phase | Phase 2 |
What NCT05669846 shows while recruiting
NCT05669846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05669846 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05669846 about?
NCT05669846 is a clinical study titled "Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC". This study is to determine if Healthy Donor FMT (hdFMT) improves the body's ability to fight cancer in patients with relapsed/refractory PD-L1 Positive NSCLC.
What is the current status of trial NCT05669846?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2025-01-08. Estimated completion is 2036-12-31.
What conditions does trial NCT05669846 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05669846?
The interventions under investigation include: Pembrolizumab (DRUG), Healthy Donor Fecal Microbiota Transplant (hdFMT) (DRUG).
Who is sponsoring clinical trial NCT05669846?
This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05669846 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05669846's enrollment target sits among peer trials
26 403rd of 454 higher than 50 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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