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Chemotherapy
Immunotherapy + Radiation for Advanced Non-Small Cell Lung Cancer (IRRADIATE-Lung Trial)
Phase 2
Recruiting
Led By Vamsidhar Velcheti
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented, metastatic NSCLC with no previous systemic therapy
Be at least 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 70 (1 year following completion of treatment cycle 6 - each cycle is 21 days)
Awards & highlights
IRRADIATE-Lung Trial Summary
This trial tests if a common cancer radiation treatment can improve results when used with chemo and immunotherapy. Patients with advanced or recurrent NSCLC can join.
Who is the study for?
This trial is for adults with advanced Stage IV NSCLC who haven't had systemic therapy before. Participants need at least one measurable lung lesion outside the radiation field, must not be pregnant or breastfeeding, and agree to use contraception. They can't join if they have active infections, other cancers needing treatment, certain autoimmune diseases, a history of severe allergies to pembrolizumab components, or are on immunosuppressants.Check my eligibility
What is being tested?
The study tests whether low dose radiation alongside standard pembrolizumab (an immunotherapy drug) and chemotherapy improves outcomes in advanced lung cancer patients. It's designed for those with untreated Stage IV NSCLC to see if symptom control through radiation can boost the effectiveness of these treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs or liver, infusion-related symptoms such as fever or chills during drug administration, fatigue from chemotherapy and skin irritation from radiation. Each patient may experience side effects differently.
IRRADIATE-Lung Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer has spread and hasn't been treated with drugs yet.
Select...
I am 18 years old or older.
Select...
I can carry out all my self-care but cannot do heavy physical work.
Select...
I have a tumor larger than 1 cm that's not in the radiation treatment area.
IRRADIATE-Lung Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 70 (1 year following completion of treatment cycle 6 - each cycle is 21 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 70 (1 year following completion of treatment cycle 6 - each cycle is 21 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR) by End of Treatment Cycle 4
Secondary outcome measures
Durable Overall Response Rate at Week 52
Duration of Local Control
Overall Survival (OS) at Final Follow-Up
+1 moreIRRADIATE-Lung Trial Design
1Treatment groups
Experimental Treatment
Group I: Untreated Patients With Stage IV NSCLCExperimental Treatment3 Interventions
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Radiation
2003
Completed Phase 3
~1020
Chemotherapy
2003
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,686 Total Patients Enrolled
Vamsidhar VelchetiPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent tests show my organs are functioning well.I have at least 2 large, measurable cancer spread sites, with one not treated by radiation.I have been diagnosed with HIV.I have not had radiation in the same area where I am now planning to have it.You have a disease that can be measured using a specific medical guideline.I have a history of autoimmune disorders or lung issues that needed steroids.My lung cancer has spread and hasn't been treated with drugs yet.I have not received a live vaccine within the last 30 days, except for the flu shot.I have recovered from previous treatment side effects and do not have an active autoimmune disease needing strong medication.I am 18 years old or older.I am a man who can father children and will use birth control as required, or I practice abstinence.I have an active tuberculosis infection.I have received chemotherapy, immunotherapy, or targeted therapy in the last 6 months.I can carry out all my self-care but cannot do heavy physical work.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have stable brain metastases and haven't taken steroids for 3 days before starting the study medication.I agree to use birth control or practice abstinence during and for 120 days after the study.I am currently being treated for an infection.I have another cancer besides skin or early cervical cancer that needs treatment.I have not had whole brain radiation therapy.You are allergic to pembrolizumab or any of the ingredients in it.I have had chemoradiation for lung cancer before.I have a tumor larger than 1 cm that's not in the radiation treatment area.You have a confirmed active Hepatitis B or Hepatitis C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Untreated Patients With Stage IV NSCLC
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.
Are participants younger than 60 years of age suitable for inclusion in this trial?
"As indicated by the inclusion criteria, this clinical trial only allows patients between 18 and 100 years of age to be enrolled."
Answered by AI
Would I qualify for participation in this trial?
"Eligibility requirements for this trial dictate that applicants must have been diagnosed with Stage IV non-small cell lung cancer and be between 18 and 100 years old. Currently, 40 patients are needed to complete the study."
Answered by AI
What is the sample size for this research endeavor?
"Affirmative. The clinical trial's page on clinicaltrials.gov indicates that the research is accepting participants, which began recruiting since its inception date of September 1st 2023 and was revised most recently on November 1st 2023. 40 test subjects are needed at one site specifically."
Answered by AI
To what extent may Untreated Patients With Stage IV NSCLC present a risk to individuals?
"Based on a ranking system of 1 to 3, we give Untreated Patients With Stage IV NSCLC a safety score of 2. This is because the trial in question is at Phase 2 and there are some studies that have assessed its safety but none that have evaluated efficacy."
Answered by AI
Is enrolment still open for this clinical research project?
"Indeed, data available on clinicaltrials.gov reveals that this medical trial was initially posted on September 1st 2023 and is actively in search of participants. 40 patients must be sourced from one site for the study to continue."
Answered by AI
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