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NCT04856176 · ClinicalTrials.gov registry record · Phase 2
A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy
A Phase 2 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04856176: Clinical Trial Phase 2 study, sponsored by Tufts Medical Center.
NCT04856176 is a Phase 2 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04856176, a Phase 2 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of programmed cell death 1 (PD-1) inhibitors in advanced lung cancer, such as pembrolizumab, there has been an improvement in overall response rates (ORR) and survival compared to chemotherapy. However, there is still a need for improvement in response rates in first-line treatments for patients with stage 4 NSCLC without genetically targetable alterations, especially in those patients with PDL-1 \<50%. This trial is important because it seeks to discover whether the responses seen in first line treatments with PD-1 inhibitors + chemotherapy can be augmented with the addition of GM-CSF during the maintenance phase with pembrolizumab +/- pemetrexed.
Primary Outcome
Progression is measured according to RECIST 1.1 criteria.
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG pemetrexed
- DRUG Granulocyte-Macrophage Colony-Stimulating Factor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2024-12-06 |
| Phase | Phase 2 |
Why NCT04856176 stopped before completion
NCT04856176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04856176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04856176 about?
NCT04856176 is a clinical study titled "A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy". Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of programmed cell death 1 (PD-1) inhibitors in advanced lung cancer, such as pembrolizumab, there has been an improvement in overall response rates (ORR) and survival ...
What is the current status of trial NCT04856176?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2022-01-03. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT04856176?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG), pemetrexed (DRUG), Granulocyte-Macrophage Colony-Stimulating Factor (DRUG).
Who is sponsoring clinical trial NCT04856176?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04856176's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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