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 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 <50%

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Non-small cell lung cancer
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Overview
Principal Investigator: Lori Pai, MD

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  response rates 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 Non Small Cell Lung Cancer (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.

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Latoya Marshall

Study details
Inclusion Criteria
  • Stage 4 NSCLC or stage 3B/3C unable to receive chemoradiation with no EGFR or ALK mutations.
  • Patients with PDL-1 of <50%.
  • No previous history of immunotherapy treatment
Exclusion Criteria
  • Receiving systemic glucocorticoids or other immunosuppressive treatment
  • Untreated brain metastases
  • Active autoimmune disease
Study Requirements

Patients will be enrolled into this study at time of maintenance therapy with immunotherapy.

Patients will be given a drug diary so that their compliance with GM-CSF can be tracked.  Subjects will record the date and time of administration in the provided diary on Days 2 through 15 of each cycle of maintenance therapy.  

At the start of each cycle the following assessments will be completed: physical exam, vital signs, weight, level of physical functionality, other medication review, review side effects, blood draw (approximately 8 teaspoons)

Blood samples (approximately 4 teaspoons) will be collected for correlative studies from consenting patients at the following time points: C1D1, C2D1, and C4D1.

CT scan of the chest, abdomen, and pelvis will be done at Screening and every 12 weeks thereafter (+/- 7 days) until disease progression.

Once disease progression is documented, subjects will enter a survival follow up period every 3 months until death. Follow up may be accomplished via clinic visit, phone call, or other avenues as appropriate.