A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 1, 2025 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Tufts Medical Center
- Interventions being studied
- Drug: Granulocyte-Macrophage Colony-Stimulating Factor; Drug: Pembrolizumab; Drug: pemetrexed; Drug: Paclitaxel; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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.
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Tufts Medical CenterBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 1, 2025. Always confirm current availability with the study team.