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Chemotherapy
Immunotherapy + Radiotherapy for Non-Small Cell Lung Cancer (SPRINT Trial)
Phase 2
Waitlist Available
Led By Balazs Halmos, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male/female participants who are at least 18 years of age with histologically confirmed diagnosis of non-small cell lung cancer
ECOG performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
SPRINT Trial Summary
This trial is testing if a new combination of immunotherapy and radiotherapy can shrink tumors more than the standard combination of chemotherapy and radiotherapy for people with lung cancer.
Who is the study for?
This trial is for adults with untreated, measurable non-small cell lung cancer (NSCLC) that's not surgically removable. They must have good performance status, no brain metastases or severe illnesses, and agree to use contraception. Excluded are those with prior certain immunotherapies, active cancers besides NSCLC, serious infections or immune conditions that could affect the study.Check my eligibility
What is being tested?
The study tests if a personalized radiotherapy schedule combined with immunotherapy (PembroRT) is more effective than the standard chemo-radiotherapy (ChemoRT) in NSCLC patients whose tumors show high levels of PD-L1.See study design
What are the potential side effects?
Potential side effects include inflammation-related symptoms due to immunotherapy, typical chemotherapy side effects like nausea and fatigue, as well as skin reactions from radiotherapy.
SPRINT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a confirmed diagnosis of non-small cell lung cancer.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My lung cancer is at an early stage and hasn't been treated yet.
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I had a PET/CT scan showing active cancer in my lungs or chest lymph nodes within the last 42 days.
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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
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I am a male and agree to use contraception and not donate sperm.
SPRINT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival
Secondary outcome measures
Distant metastisis
Intrathoracic disease progression
Overall survival
SPRINT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PembroRT CohortExperimental Treatment1 Intervention
Subjects with PD-L1 expression ≥ 50% Combination of pembrolizumab and dose-painted radiotherapy for locally advanced NSCLC patients with high (≥ 50%) PD-L1 expression.
Group II: ChemoRT CohortActive Control1 Intervention
Subjects with PD-L1 expression < 50% Subjects with PD-L1 expression below 50% will be enrolled and treated with standard concurrent chemoradiotherapy.
Find a Location
Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
286 Previous Clinical Trials
11,856,944 Total Patients Enrolled
Montefiore Medical CenterOTHER
441 Previous Clinical Trials
582,159 Total Patients Enrolled
Balazs Halmos, MDPrincipal InvestigatorMontefiore Medical Center
2 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fluid buildup due to cancer in my chest or around my heart.I am severely allergic to pembrolizumab or its ingredients.I am 18 or older with a confirmed diagnosis of non-small cell lung cancer.I am currently being treated for a cancer other than lung cancer.I have an autoimmune disease but it's not severe and doesn't require strong medication.I cannot undergo the specific type of radiotherapy outlined in the study.My vital organs are functioning well according to recent tests.My lung cancer is at an early stage and hasn't been treated yet.I had a PET/CT scan showing active cancer in my lungs or chest lymph nodes within the last 42 days.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I have an immune system disorder or have been on steroids recently.I have had or currently have lung inflammation treated with steroids.I have an active tuberculosis infection.I am fully active and can carry on all my pre-disease activities without restriction.Women who could become pregnant need to take a pregnancy test within 72 hours before starting the study. If the test is positive, they cannot participate.You need to have had a lung function test within 42 days before joining the study.I don't have any health issues that could affect the study results or my participation.You have mental health or substance abuse issues that could make it hard for you to follow the trial's rules.You need to have had a brain MRI or head CT with contrast within the last 42 days before joining the study.I have previously been treated with specific immunotherapy drugs.I have not received a live vaccine in the last 30 days.I am a male and agree to use contraception and not donate sperm.I have not had systemic therapy for lung cancer in the last year.I am currently taking medication for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: PembroRT Cohort
- Group 2: ChemoRT Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the population for this experiment confined to those over 65 years of age?
"This trial is restricted to individuals aged 18-99. Nonetheless, there are 28 studies for patients younger than the designated age range and 1525 trials that cater to persons over 65 years old."
Answered by AI
Are there any open recruitment opportunities for this clinical experiment?
"This clinical trial is not presently recruiting candidates, as indicated by the data stored on clinicialtrials.gov. This specific study was initially posted on August 30th 2018 and has been edited for the last time on July 11th 2022. However, there are currently 1,527 other medical trials actively looking for participants to join their research team."
Answered by AI
Could I potentially participate in this clinical trial?
"This clinical trial seeks 37 individuals aged 18-99 with carcinoma, non-small-cell lung. Eligible applicants must have had a Whole body PET/CT within 42 days of enrolment that demonstrates hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If the test was taken more than 42 days ago but is not repeated, there must be a CT scan from 28 days prior showing no metastatic disease. Additionally, candidates should fit criteria for AJCC version 8 Stage II disease; medically or technically unresectable; ECOG performance status 0 to 1."
Answered by AI
Has the Federal Drug Administration sanctioned PembroRT?
"PembroRT's safety rating is 2 on the 1-3 scale, due to preliminary data that suggest it is secure while efficacy has yet to be corroborated."
Answered by AI
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