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NCT04037462 · ClinicalTrials.gov registry record · Phase 1
Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy
A Phase 1 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04037462: Clinical Trial Phase 1 study, sponsored by VA Office of Research and Development.
NCT04037462 is a Phase 1 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04037462, a Phase 1 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Lung cancer accounts for 30% of all cancers among American war Veterans and remains the leading cause of cancer related deaths. Half of all lung cancers are metastatic non-small cell lung cancer (NSCLC), with a 2-year survival rate of 10%. Immunotherapy with immune checkpoint inhibitors (ICI) has emerged as a promising therapeutic strategy that aims to harness the immune system to fight lung cancer. However, given the modest response rates of 20-25% to these immune checkpoint inhibitors, there is a greater desire to extend their benefits to more patients. Along with the desire to extend their benefits, there is a critical need for the development of novel approaches that can expand the benefit from immune checkpoint inhibitors and create more durable responses, prolonging survival from lung cancer. The investigators' studies show that extended dexamethasone (Dex) treatment induces irreversible cell cycle blockade and a senescence phenotype through chronic activation of the p27Kip1 gene in glucocorticoid receptor (GR) overexpressing lung adenocarcinoma (AC) cell populations. Further, following withdrawal of Dexamethasone, proteins associated with the senescence associated secretory phenotype (SASP) strongly attracted and expanded T-cells, NK cells and monocytes stimulated tumor cell cytolytic activity of NK cells. Therefore, dexamethasone may induce a persistent senescence phenotype in tumor cell sub-populations expressing moderate/high levels of GR and resultant chemokines produced by the senescent cells will mobilize host immune cells to reboot response to immune checkpoint inhibitors following complete Dexamethasone withdrawal.
Primary Outcome
In the first stage, three Dex escalation cohorts will be evaluated sequentially from Cohort A to Cohort C until \> 2 patients exhibit FLT-PET response (i.e., 30% reduction in FLT-PET uptake in at least one target lesion); otherwise, the trial will be terminated due to futility. The SUVmax will be measured at baseline and after Dex run-in and wash out period. For example, in Cohort A, patients will get an FLT- PET at baseline, then receive Dexamethasone 4mg PO BID given for 7 days, followed by t
Interventions
- DRUG Dexamthasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-07-07 |
| Est. Completion | 2023-02-23 |
| Phase | Phase 1 |
Why NCT04037462 stopped before completion
NCT04037462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexamthasone is the first listed.
NCT04037462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04037462 about?
NCT04037462 is a clinical study titled "Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy". Lung cancer accounts for 30% of all cancers among American war Veterans and remains the leading cause of cancer related deaths. Half of all lung cancers are metastatic non-small cell lung cancer (NSCLC), with a 2-year survival rate of 10%. Immunotherapy with immune checkpoint inhibitors (ICI) has em...
What is the current status of trial NCT04037462?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-07-07. Estimated completion is 2023-02-23.
What interventions are being tested in trial NCT04037462?
The interventions under investigation include: Dexamthasone (DRUG).
Who is sponsoring clinical trial NCT04037462?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04037462's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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