Clinical Trials

Study Overview

Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study

This phase II trial studies how well pembrolizumab works in preventing development of lung cancer in patients with high-risk pulmonary nodules. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Trial identification number

NCT03634241

The medicine(s) being studied.

Pembrolizumab, a commercially available immunotherapy

How does the new medicine work (Mechanism of Action)?

Pembrolizumab is like a security guard for your body's immune system. Normally, cancer cells wear a "cloak" that makes them invisible to your immune system's "guards." Pembrolizumab works by taking away this cloak, revealing the cancer cells to your immune system. Once the cancer cells are visible, your body's natural defenses can attack and destroy them. This medication essentially helps your body recognize and fight cancer more effectively.

What will be evaluated (Key endpoints)?

Primary objective: The goal is to see if pembrolizumab, a drug that helps the immune system fight cancer, can get rid of high-risk lung nodules that haven't changed in size over two CT scans taken 3 months apart. This will be checked 6 months after starting the treatment.

Who may participate (Inclusion criteria)?

People without lung cancer history, showing lung nodules with a 10-30% chance of being cancerous, based on specific predictions.
Those with lung nodules over 30% chance of being cancerous but confirmed not malignant through biopsy.
Individuals with a history of early-stage lung cancer, who've completed treatment, showing persistent lung nodules.
Criteria for eligibility include being 18 or older, agreeing to specific contraceptive measures, providing informed consent, having a certain health status, and meeting organ function requirements as outlined.

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Who may not participate (Exclusion criteria)?

Excludes those with certain lung diseases needing oxygen, recent steroid treatment for lung issues, positive pregnancy tests for women of childbearing potential, previous treatments with specific anti-cancer drugs, and those with untreated or active infections like HIV or hepatitis.

List of participating clinical trials sites

New York:

Daniel H. Sterman, MD | NYU Langone Health

Contact: 212-731-6162

daniel.sterman@nyulangone.com

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Texas:

Jianjun Zhang — MD Anderson Cancer Center

Contact: 713-792-6363

JZhang20@mdanderson.org

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Any other information

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scans and collection of blood samples throughout the trial.

After conclusion of study treatment, patients are followed up at 3 and 6 months.

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Key points:

Emphasis on patient safety, with requirements for contraceptive use to prevent pregnancy during and after treatment.
The need for informed consent and satisfactory health status to participate.
Exclusion of participants with certain pre-existing conditions or treatments that could interfere with study outcomes.

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Link to clinicaltrials.gov

Lung Cancer Prevention in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules

Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study