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TERMINATED
NCT04856176
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Granulocyte-Macrophage Colony-Stimulating Factor

250 mcg

DRUG

Pembrolizumab

200mg every 3 weeks

DRUG

pemetrexed

500mg/m2

DRUG

Paclitaxel

200mg/m2

DRUG

Carboplatin

AUC 5/6

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States