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A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy
Sponsor: Tufts Medical Center
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.
Official title: A Phase II Trial of GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed After Completion of First Line Chemo-Immunotherapy in Advanced Non-Small Cell Lung Cancer Patients With PDL-1 of 1%-49%
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2022-01-03
Completion Date
2024-12-06
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
Granulocyte-Macrophage Colony-Stimulating Factor
250 mcg
Pembrolizumab
200mg every 3 weeks
pemetrexed
500mg/m2
Paclitaxel
200mg/m2
Carboplatin
AUC 5/6
Locations (1)
Tufts Medical Center
Boston, Massachusetts, United States