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Chemotherapy
Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer (G360-IIT Trial)
Phase 2
Recruiting
Led By Martin Gutierrez, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator
AST, ALT < 2.5 x ULN with no liver metastases or < 5x ULN with the presence of liver metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of time from first treatment to time of death, up to 36 months
Awards & highlights
G360-IIT Trial Summary
This trial will study if ctDNA can help predict which NSCLC patients need immunotherapy and/or chemo to treat their cancer.
Who is the study for?
Adults over 18 with newly diagnosed, untreated Stage IV NSCLC and positive PD-L1 expression. They must have proper liver function, no severe heart conditions or autoimmune diseases, not be pregnant or breastfeeding, agree to use contraception, and have no other cancers unless in remission for 2+ years.Check my eligibility
What is being tested?
The trial is testing if ctDNA levels can predict who will benefit from immunotherapy alone (Nivolumab/Ipilimumab) versus those needing both immunotherapy and chemotherapy (Carboplatin/Paclitaxel/Pemetrexed). Participants are selected based on their ctDNA profile.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea, blood cell changes increasing infection risk. Chemotherapy may cause hair loss, nerve damage and more intense digestive issues.
G360-IIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured and hasn't been treated with radiation.
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My liver enzymes are within acceptable limits for my cancer condition.
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I am over 18 years old.
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I can take care of myself and perform daily activities.
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I have Stage IV non-small cell lung cancer and haven't started treatment.
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My cancer tests positive for PD-L1 expression of 1% or more.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
G360-IIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of time from first treatment to time of death, up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of time from first treatment to time of death, up to 36 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 (PFS)
Secondary outcome measures
Duration of Response
Objective Response Rate
Overall Survival
+2 moreG360-IIT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment2 Interventions
Arm B - control arm (Immunotherapy only)
Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks
Group II: Arm AActive Control5 Interventions
Arm A - Intervention arm (Immunotherapy and Chemotherapy)
Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks
Platinum- doublet Chemotherapy (Histology-based) 4 cycles depending on the investigator's discretion.
Carboplatin dosed at AUC 5, and either Paclitaxel 175 mg/m2 for squamous or Pemetrexed 500 mg/m2 for non-squamous
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,136 Total Patients Enrolled
MedSIROTHER
45 Previous Clinical Trials
23,269 Total Patients Enrolled
Martin Gutierrez, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate numbness or pain in my hands or feet.I have a tumor that can be measured and hasn't been treated with radiation.I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.I have lung disease that could affect my treatment's safety monitoring.You are willing to have multiple blood tests to check for specific genetic material as needed for the study.I need to get a Guardant360 CDx test before joining.I finished any palliative radiotherapy (not to the brain) at least 2 weeks ago.I am not pregnant, not breastfeeding, and either use effective birth control or cannot have children.I had cancer before, but it's been in complete remission for over 2 years, except for certain skin or in situ cancers.I do not have serious heart problems or conditions that a doctor would worry about in a study.You have a positive test for hepatitis B virus or hepatitis C virus, which means you have an active infection.You have a known autoimmune disease that is currently active or suspected.I am younger than 18 years old.My liver enzymes are within acceptable limits for my cancer condition.I do not have untreated brain metastases.I have cancer cells in the fluid around my brain and spinal cord.I am over 18 years old.Your hemoglobin level is higher than 9 grams per deciliter.I can take care of myself and perform daily activities.You are not expected to live longer than 12 weeks.I have Stage IV non-small cell lung cancer and haven't started treatment.Your platelet count is higher than 100,000 per cubic millimeter.You are expected to live for at least 12 more weeks.I have another cancer that needs treatment at the same time.I have recovered from major surgery or a serious injury for at least 14 days.My cancer tests positive for PD-L1 expression of 1% or more.My cancer does not have mutations like EGFR, ALK, ROS1, MET, or RET that can be treated with specific drugs.I am willing to use condoms during the trial.Your ANC is higher than 1500 cells/mm3.My organs are working well.My kidney function, measured by creatinine levels or clearance, is within the required range.My blood test shows very low or no cancer DNA.My bilirubin levels are within the normal range, considering my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.
What is the current status of Arm A in terms of FDA validation?
"Our company has given Arm A a score of 2, as there is limited evidence that this drug can be safely administered, but no data to suggest its efficacy."
Answered by AI
Are there remaining vacancies in this research investigation?
"As indicated on clinicaltrials.gov, the study which was initially published on February 15th 2023 has ceased recruitment of participants and is no longer accepting applications. However, there are 1329 other trials currently enrolling patients worldwide."
Answered by AI
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