A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advanced Non-small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: Partner Therapeutics, Inc.
• Treatments: Carboplatin; Molgramostim; Paclitaxel; Pembrolizumab; Pemetrexed; Sargramostim

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. Histologically confirmed stage 4 NSCLC or stage 3B/3C not able to receive chemoradiation with no sensitizing EGFR or ALK mutations.

3. PDL-1 of 1%-49%

4. No previous history of immunotherapy treatment

5. ECOG PS 0-1

6. At least one measurable lesion according to RECIST version 1.1

7. Life expectancy of at least 3 months.

8. Able to self-administer daily GM-CSF injections

9. Eligible for treatment with 4 cycles of chemoimmunotherapy followed by maintenance therapy with pembrolizumab +/- pemetrexed.

Exclusion Criteria:

1. Receiving systemic glucocorticoids or other immunosuppressive treatment

2. Untreated brain metastases

3. Active autoimmune disease

4. Active interstitial lung disease, pneumonitis

5. Solid organ transplant recipients

6. Subject may not participate in another drug research study while participating in this research study

7. Pregnant patients

8. Known hypersensitivity to GM-CSF (sargramostim)