A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance No… (NCT04856176) | Clinical Trial Compass
TerminatedPhase 2
A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy
Stopped: Futility
United States5 participantsStarted 2022-01-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. Histologically confirmed stage 4 NSCLC or stage 3B/3C not able to receive chemoradiation with no sensitizing EGFR or ALK mutations.
✓. PDL-1 of 1%-49%
✓. No previous history of immunotherapy treatment
✓. ECOG PS 0-1
✓. At least one measurable lesion according to RECIST version 1.1
✓. Life expectancy of at least 3 months.
✓. Able to self-administer daily GM-CSF injections
Exclusion criteria
✕. Receiving systemic glucocorticoids or other immunosuppressive treatment