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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 is a Phase 2 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04856176
The ClinicalTrials.gov registry entry for NCT04856176 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04856176 reports 0 study locations.
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.
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