NCT04856176TerminatedPhase 2
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 1%-49%
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Reason given: Futility
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 19 Apr 2021
- Start date
- 3 Jan 2022
- Primary completion date
- 6 Dec 2024
- Lead sponsor
- Tufts Medical Center
- Diseases
- Lung cancer
- NCT number
- NCT04856176
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving systemic glucocorticoids or other immunosuppressive treatment
- Solid organ transplant recipients
- Subject may not participate in another drug research study while participating in this research study
Other illness
- Active autoimmune disease
- Active interstitial lung disease, pneumonitis
- Known hypersensitivity to GM-CSF (sargramostim)
Other
- Untreated brain metastases
- Pregnant patients
Who the study is looking for
- 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
- Eligible for treatment with 4 cycles of chemoimmunotherapy followed by maintenance therapy with pembrolizumab +/- pemetrexed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.