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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

Must not have

Subjects with Grade 2 peripheral neuropathy

Significant uncontrolled cardiovascular disease, including but not limited to, any of the following: Uncontrolled hypertension, Active coronary artery disease, Myocardial infarction in the past 6 months, History of congenital long QT syndrome, History of clinically significant arrhythmias, Uncontrolled heart failure, History of a current diagnosis of myocarditis, Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of time from first treatment to time of death, up to 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate numbness or pain in my hands or feet.

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I do not have serious heart problems or conditions that a doctor would worry about in a study.

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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

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I have lung disease that could affect my treatment's safety monitoring.

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I am younger than 18 years old.

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I do not have untreated brain metastases.

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I have cancer cells in the fluid around my brain and spinal cord.

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I have another cancer that needs treatment at the same time.

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My cancer does not have mutations like EGFR, ALK, ROS1, MET, or RET that can be treated with specific drugs.

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My blood test shows very low or no cancer DNA.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Duration of Response

Objective Response Rate

Overall Survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Ipilimumab

2015

Completed Phase 3

~3420

Nivolumab

2015

Completed Phase 3

~4010