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Checkpoint Inhibitor

Immunotherapy + Local Consolidation Therapy for Lung Cancer

Phase 3
Recruiting
Led By John V Heymach
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For lung adenocarcinoma patients, patients must not harbor any EGFR sensitizing or ALK fusion where there are standard care therapy options available. For patients with histologies other than adenocarcinoma, EGFR and ALK status is not required. Adenocarcinoma patients may be consented prior to the EGFR and ALK status being known, but EGFR and ALK status must be determined prior to initiating therapy. EGFR and ALK status may be determined using either tumor- or plasma-based, Clinical Laboratory Improvement Amendments (CLIA)-certified assays. For patients with non-small cell lung cancer (NSCLC), not otherwise specified (NOS), EGFR/ALK testing is not required, as the frequency of alterations is exceedingly rare in this histology. Also, note that patients with ROS1/RET alterations can be enrolled, as tyrosine kinase inhibitor such as crizotinib aren't established as first line therapy for patients with these alterations.
Histologically or cytologically confirmed non-small cell lung cancer; if a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer may be consented, but pathology must be confirmed prior to initiating treatment on study. Neuroendocrine carcinomas (e.g. small cell lung cancer [SCLC], carcinoid tumors) are not eligible. Carcinomas with neuroendocrine differentiation are eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after completion of study treatment
Awards & highlights

Study Summary

This trial is testing whether adding immunotherapy to standard local consolidation therapy can improve outcomes for patients with stage IV non-small cell lung cancer.

Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer. Eligible participants must have measurable disease, adequate organ function, and no prior immunotherapy for metastatic NSCLC. Women of childbearing potential must test negative for pregnancy and use contraception, as should men if their partners are of childbearing potential. Patients with treated brain metastases may qualify if stable.Check my eligibility
What is being tested?
The study is testing the effectiveness of nivolumab and ipilimumab (immunotherapy drugs) with or without local consolidation therapy (surgery or radiation) in treating advanced lung cancer. The goal is to see if adding local treatments to immunotherapy improves outcomes compared to immunotherapy alone.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, fatigue, skin issues, hormone gland problems like thyroid disorders, infusion reactions during drug administration, and possible increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer does not have common EGFR or ALK mutations, or if it does, there's no standard treatment for them.
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My lung cancer is confirmed and not small cell or carcinoid type.
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I am a man, sexually active with a woman capable of bearing children, and will use effective contraception.
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My brain metastases are treated, I'm neurologically stable, and not on high steroids.
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I may have had radiation for cancer spread but still have at least one untreated spot.
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I have signed and understand the consent form according to the study's rules.
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I've had one round of treatment for my cancer after it spread, including drugs to stop new blood vessels from forming.
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My kidney function tests are within the normal range.
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I am using or willing to use birth control as required if I can have children.
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My cancer is stage IV and can be measured for changes.
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I have taken a pregnancy test within the last 48 hours and it was negative.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OS in oligometastatic subgroup
Overall survival (OS) in overall population

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (ipilimumab, nivolumab, LCT)Experimental Treatment6 Interventions
INDUCTION PHASE: Patients receive nivolumab IV over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients receive LCT consisting of surgery and/or radiation 14 days after completion of Induction Phase. Patients then receive nivolumab and ipilimumab as in arm A beginning within 4 weeks after LCT. Courses repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (ipilimumab, nivolumab)Experimental Treatment3 Interventions
INDUCTION PHASE: Patients receive nivolumab IV over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients receive nivolumab IV over 60 minutes on days 1, 15, and 29 and ipilimumab IV over 90 minutes on day 1. Courses repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,414 Total Patients Enrolled
John V HeymachPrincipal InvestigatorM.D. Anderson Cancer Center
John V Heymach, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03391869 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm B (ipilimumab, nivolumab, LCT), Arm A (ipilimumab, nivolumab)
Non-Small Cell Lung Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03391869 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03391869 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What disease is Local Consolidation Therapy most effective in treating?

"Local Consolidation Therapy is a type of treatment that is often used after anti-angiogenic therapy. It can also be effective in treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Are we still able to enroll patients in this research project?

"This trial is still enrolling patients, according to the information available on clinicaltrials.gov. The listing for this study was first created on December 29th, 2017 and was most recently edited on November 8th, 2020."

Answered by AI

How many places are coordinating this clinical trial?

"There are six enrolling patients for this clinical trial. Three of those locations are MD Anderson in Sugar Land, MD Anderson League City and M D Anderson Cancer Center in Conroe. The other 6 sites are _____."

Answered by AI

What are the most recent findings from research on Local Consolidation Therapy?

"At the moment, there are 796 active clinical trials researching Local Consolidation Therapy. 86 of those trials have progressed to Phase 3. The majority of these Local Consolidation Therapy trials originate in Pittsburgh, Pennsylvania; however, 43289 different locations across the world are trialing this treatment."

Answered by AI

What are the risks associated with Local Consolidation Therapy?

"Local Consolidation Therapy has some efficacy data supporting it and multiple rounds of safety testing, so it received a score of 3."

Answered by AI

How many people fit the screening criteria for this experiment?

"That is correct, the most recent update on clinicaltrials.gov confirms that 360 patients are needed for this study that was originally posted on December 29th, 2017. The study is looking for volunteers at six different locations."

Answered by AI

Who else is applying?

What site did they apply to?
MD Anderson in Sugar Land
What portion of applicants met pre-screening criteria?
Did not meet criteria
~83 spots leftby Dec 2025