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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post completion of accrual

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