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Pembrolizumab + Imprime PGG for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new cancer treatment that involves two drugs. The first part of the trial is testing different doses of the drugs to see what works best. The second part of the trial will test the treatment on more people to see if it is effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 25 Patients • NCT02086175Trial Design
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Who is running the clinical trial?
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- I have had chemotherapy, immune therapy, or radiation within the last 2 weeks.I have not had any non-healing wounds, fractures, or ulcers in the last 28 days.You are allergic to Chinese hamster ovary cell products or other genetically engineered human antibodies.I have untreated brain metastases.I haven't had major surgery in the last 4 weeks.I have an active Hepatitis B or C infection.My cancer worsened after first platinum-based treatment and I need second-line therapy.I am allergic to pembrolizumab or its ingredients.I have a history of blood clots but am on blood thinners.You have a known history of HIV infection.My lung cancer is at stage IV.You have had an allergic reaction to Imprime PGG or any of its ingredients in the past.My cancer has worsened after the first treatment, and I am now eligible for a second treatment.My blood test shows I have high levels of IgG anti-β-glucan antibody.Your blood needs to be working well within the last 28 days before joining the study.I do not have any severe health or mental conditions that could make this study risky for me.I am a man who can father children and will use birth control.My liver is functioning well, as tested within the last 28 days.I have had an organ or stem cell transplant.My early stage cancer has progressed within the specified time.My cancer has an EGFR or ALK mutation and no longer responds to TKI therapy.Your doctor expects you to live for at least 6 more months.I am currently taking medication that weakens my immune system.I have an autoimmune disease that could worsen with immune-boosting treatments.I am currently being treated for a serious infection.My kidney function is normal as tested within the last 28 days.I am not pregnant or breastfeeding and agree to use two forms of birth control.My cancer can be measured on scans taken within the last 28 days.I have had lung issues needing steroids or had lung inflammation from immunotherapy.I am mostly able to do my daily activities.My lung cancer is confirmed to be non-small cell type.Your blood clotting should be normal within the 28 days before joining the study.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I have an active case of tuberculosis.I am willing and able to follow the study's schedule and procedures.I have had skin, cervical, breast, prostate cancer or low-grade bladder cancer but have been disease-free for 2 years.I do not have any severe, uncontrolled conditions like diabetes or heart failure.
- Group 1: Arm A - Phase Ib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Imprime PGG previously been subject to any other clinical investigations?
"Currently, Imprime PGG has 961 active clinical trials with 122 of them in Phase 3. The majority are situated around Houston, Texas but there is a global reach encompassing 35,731 research sites."
What are the usual indications for Imprime PGG?
"Imprime PGG is typically prescribed to combat neoplasms, however it has also been shown to be an effective treatment for many other medical conditions such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
How many participants have been approved for this clinical experiment?
"Unfortunately, this clinical trial has ceased its participant recruitment process. Initially posted on February 13th 2017 and last updated October 6th 2022; there are still many other studies seeking individuals with non-small cell lung carcinoma (nsclc) - 2045 trials to be exact - as well as 961 for Imprime PGG."
In what capacity is this clinical trial being conducted in the United States?
"As part of this trial, patients are being enrolled at the University of Iowa Hospital and Clinics in Iowa City, Indiana Univeristy Melvin and Bren Simon Cancer Center in Indianapolis, as well as Rutgers Cancer Institute of New jersey in New Brunswick. Additionally, there are 3 more sites taking part."
Is this study currently recruiting new participants?
"This trial, which was first posted on 13th February 2017 and last updated 6th October 2022, is not presently recruiting patients. However, there are 3.006 other trials that have current openings for potential participants."
What are the key goals of this medical research experiment?
"The primary endpoint of this clinical trial, lasting twenty-one days from the onset of combination treatment until its completion, is Progression Free Survival (PFS). Secondary outcomes evaluated include 6 month PFS using RECIST v1.1 in patients with NSCLC treated with Imprime PGG alongside pembrolizumab after being unresponsive to first line treatments; Adverse Events measured through CTCAE v4 and Clinical Benefit Ratio assessed per RECIST 1.1."
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