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

NCT03634241

• Pembrolizumab, a commercially available immunotherapy

• 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.

• 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.

• 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.

• 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.

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.

‍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.

Link to clinicaltrails.gov