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Checkpoint Inhibitor

Chemoimmunotherapy + Radiation for Lung Cancer (NEORADJUVANT Trial)

Bel Air, MD
Phase 1
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential must have negative serum or urine pregnancy testing within 30 days of study start
Age greater than or equal to 18 years at time of study entry
Must not have
Participants with active autoimmune disease which would preclude immunotherapy
History of allergy or hypersensitivity to nivolumab, or chemotherapy agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post completion of accrual
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking to see if giving radiation before chemoimmunotherapy and surgery is helpful for people with non-small cell lung cancer who may have surgery. The standard treatment involves chemotherapy and an immun

Who is the study for?
This trial is for individuals with borderline resectable non-small cell lung cancer (NSCLC) who may be candidates for surgery. Participants should not have had prior treatments for NSCLC and must be able to undergo chemotherapy, immunotherapy with nivolumab, and stereotactic body radiation therapy (SBRT).
What is being tested?
The study tests if adding SBRT before standard chemoimmunotherapy improves outcomes in NSCLC patients eligible for surgery. Patients receive three doses of SBRT followed by up to three cycles of chemotherapy combined with the immunotherapy drug nivolumab before a surgical assessment.
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy like nausea, hair loss, fatigue; immune-related issues from nivolumab such as rash or colitis; and localized skin irritation or damage to nearby organs from SBRT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have confirmed I am not pregnant through a test in the last 30 days.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tumor tissue is available for genetic testing.
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My lung cancer is at an advanced stage but might still be removable with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an active autoimmune disease that prevents immunotherapy.
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I am allergic to nivolumab or certain chemotherapy drugs.
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My cancer has spread to other parts of my body, including the lining of my lungs.
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My cancer has spread to lymph nodes near my collarbone or neck.
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I haven't taken steroids or immunosuppressants in the last 14 days.
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My cancer is identified as large-cell neuroendocrine carcinoma.
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I have received early-stage lung cancer treatment before.
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I have active hepatitis B or C.
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I have been treated with specific immune system targeting drugs before.
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I do not have poorly controlled or untreated HIV/AIDS.
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I haven't had any cancer except for treatable ones in the last 3 years.
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I am not pregnant, breastfeeding, and willing to use birth control.
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My cancer has specific genetic changes known as EGFR mutations or ALK translocation.
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I have cancer that has spread to my brain.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tolerability of Adding Sub-ablative, Immunosensitizing, Radiotherapy to Standard of Care Neoadjuvant Chemoimmunotherapy
Secondary study objectives
Major Pathologic Response Rate (MPR)
Measure rate of definitive resection
Number of adverse events assessment by CTCAE v5.0 that are related to treatment
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SBRT+Chemoimmunotherapy +/-SurgeryExperimental Treatment4 Interventions
Standard of care chemotherapy along with nivolumab. Nivolumab will be infused every 3 weeks for up to 3 cycles. Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine. Concurrently patient will receive 3 fractions of SBRT. Patient will then be evaluated for possible surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Resection
2018
Completed Phase 2
~420
Nivolumab
2014
Completed Phase 3
~3880
Chemotherapy
2003
Completed Phase 4
~2850
SBRT
2014
Completed Phase 2
~1060

Find a Location

Closest Location:Upper Chesapeake- Kaufman Cancer Center· Bel Air, MD· 356 miles

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
723 Previous Clinical Trials
532,063 Total Patients Enrolled
~12 spots leftby Mar 2028