Status:
TERMINATED
A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Partner Therapeutics, Inc.
Conditions:
Advanced Lung Non-Small Cell Carcinoma
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Lung cancer is the most commonly diagnosed cancer worldwide. Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of prog...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Receiving systemic glucocorticoids or other immunosuppressive treatment
- Untreated brain metastases
- Active autoimmune disease
- Active interstitial lung disease, pneumonitis
- Solid organ transplant recipients
- Subject may not participate in another drug research study while participating in this research study
- Pregnant patients
- Known hypersensitivity to GM-CSF (sargramostim)
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04856176
Start Date
January 3 2022
End Date
December 6 2024
Last Update
January 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111