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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~duration of time from first treatment to time of death, up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of time from first treatment to time of death, up to 36 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
Progression Free Survival (PFS)
Secondary outcome measures
Duration of Response
Objective Response Rate
Overall Survival
+2 more

G360-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
~2610

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
132 Previous Clinical Trials
29,365 Total Patients Enrolled
MedSIROTHER
46 Previous Clinical Trials
23,509 Total Patients Enrolled
Martin Gutierrez, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05715229 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm A, Arm B
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05715229 — Phase 2
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715229 — Phase 2

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
Recent research and studies
~72 spots leftby Apr 2026