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Alkylating Agent

Sargramostim + Pembrolizumab for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible for treatment with 4 cycles of chemoimmunotherapy followed by maintenance therapy with pembrolizumab +/- pemetrexed
Histologically confirmed stage 4 NSCLC or stage 3B/3C not able to receive chemoradiation with no sensitizing EGFR or ALK mutations
Must not have
Untreated brain metastases
Solid organ transplant recipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is important because it seeks to improve response rates in first-line treatments for patients with stage 4 NSCLC without genetically targetable alterations, especially in those patients with PDL-1 <50%.

Who is the study for?
This trial is for adults over 18 with stage 4 NSCLC or certain stage 3B/3C lung cancers, who've had chemoimmunotherapy but no immunotherapy before. They should be able to self-inject GM-CSF, have a life expectancy of at least 3 months, and an ECOG performance status of 0-1. Patients with active lung disease, untreated brain metastases, autoimmune diseases, or those on immunosuppressants can't join.
What is being tested?
The study tests if adding Sargramostim (GM-CSF) to maintenance therapy with Pembrolizumab +/- Pemetrexed after initial treatment improves outcomes in advanced NSCLC patients. It explores whether this combination can boost the effectiveness seen with PD-1 inhibitors plus chemotherapy.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, infusion-related reactions from the drugs being tested and potential injection site reactions due to GM-CSF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a specific cancer treatment plan including pembrolizumab.
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My lung cancer is at an advanced stage and cannot be treated with chemoradiation.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I can give myself daily injections.
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My cancer's PDL-1 level is between 1% and 49%.
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I have never received immunotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that have not been treated.
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I have received a solid organ transplant.
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I have an active lung condition.
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I am currently taking steroids or other drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Progression free survival (PFS)
Secondary study objectives
To evaluate changes in CD4 T at different time points during study treatment
To evaluate changes in CD8 T at different time points during study treatment
To evaluate changes in PD-1+ CD4 at different time points during study treatment
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GM-CSF Plus Maintenance Pembrolizumab +/- PemetrexedExperimental Treatment5 Interventions
All patients will receive GM-CSF plus maintenance pembrolizumab with or without pemetrexed, following completion of 4 cycles of chemo-immunotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
pemetrexed
2005
Completed Phase 3
~5000
Paclitaxel
2011
Completed Phase 4
~5370
Granulocyte-Macrophage Colony-Stimulating Factor
2017
Completed Phase 1
~20
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,378 Total Patients Enrolled
Partner Therapeutics, Inc.Industry Sponsor
6 Previous Clinical Trials
818 Total Patients Enrolled

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04856176 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04856176 — Phase 2
Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04856176 — Phase 2
~0 spots leftby Dec 2024
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