← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am eligible for a specific cancer treatment plan including pembrolizumab.
Select...
My lung cancer is at an advanced stage and cannot be treated with chemoradiation.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I can give myself daily injections.
Select...
My cancer's PDL-1 level is between 1% and 49%.
Select...
I have never received immunotherapy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression free survival (PFS)
Secondary outcome measures
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

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
Granulocyte-Macrophage Colony-Stimulating Factor
2017
Completed Phase 1
~20
Pembrolizumab
2017
Completed Phase 2
~2010
pemetrexed
2005
Completed Phase 3
~5000
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,931 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots currently available for participants in this trial?

"This medical study, which was initially announced on March 1st 2022, is still searching for participants according to clinicaltrials.gov; the trial's information was last changed on October 3rd of this year."

Answered by AI

What is the primary focus of this experiment?

"This clinical trial will assess Progression Free Survival (PFS) over a two year period as its primary outcome. Secondary endpoints include measuring myeloid derived suppressor cells, PD-1+ CD4 levels and CD4 T activity at different intervals during treatment."

Answered by AI

How is Pembrolizumab commonly employed to aid patients?

"Pembrolizumab is frequently utilized to treat malignant neoplasms, such as unresectable melanoma and microsatellite instability high. Moreover, it can be employed to address locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Could you explain the potential detriments of Pembrolizumab to patients?

"Our Power team evaluation of Pembrolizumab's safety is a 2, as the Phase 2 trial has provided data confirming its security yet not fully established its efficacy."

Answered by AI

How many participants are actively enrolled in this research investigation?

"Affirmative. Per the information accessible on clinicaltrials.gov, this medical research project is currently looking for enrollees. The trial was first launched in January 3rd 2022 and has been updated as of October 3rd 2022; 83 patients are needed at a single site."

Answered by AI
Recent research and studies
~20 spots leftby Dec 2024