Pembrolizumab After Lung SBRT for Medically Inoperable Early Stage Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title: A Pilot Study of Adjuvant Pembrolizumab After Lung Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to see whether patients who have early stage NSCLC bigger than a certain size might benefit from receiving additional medicinal drug to treat their cancer after the SBRT Surgeons and radiation doctors have understood for some time that the chances of cancer showing up in areas outside the chest are higher for patients with tumors bigger than 3 cm, (about 1 ¼ inches). However, it is not routine to offer chemotherapy or drug treatments after radiation or surgery for lung cancer for patients with early stage lung cancer. This is because giving extra treatment in the form of chemotherapy has not shown to help patients live longer. There has been reluctance to offer additional treatments, especially chemotherapy, to patients with lung cancer who could not have surgery because of their medical issues. Even if these patients were felt to be at a higher risk of their cancer coming back, there is hesitation because the treatments can be difficult to tolerate in frail patients.

Recently, there have been very important advances in the kinds of drug therapy that are used for lung cancer patients. These kinds of drugs are called immunotherapy since they work with the body's immune system to fight the cancer. These drugs have been shown to make patients with advanced, incurable lung cancer, live longer and also to be very safe with very limited side effects. Because of these favorable characteristics, cancer specialists are interested in using these drugs for patients with curable cancer and for patients who may be too fragile for traditional chemotherapy. In this way, patients who get SBRT are already known to be fragile so cancer doctors are interested in now studying this kind of drug in SBRT patients to see if it can make patients with large tumors do better. The idea of the study then is that the patient would receive their standard SBRT and if their tumor is of a certain size that makes the risk of the cancer showing up outside the chest higher than routine, they would be considered for getting the immunotherapy drug.

Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of head and neck cancer. However, it has not been approved for use in other cancers such as newly diagnosed early stage NSCLC. It is FDA approved for advanced NSCLC, that is people who have already had some chemotherapy and their disease has worsened. Pembrolizumab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.

Clinical Trial Description

The primary objective of this pilot safety study is to determine the tolerability and feasibility of administering pembrolizumab in the adjuvant setting following completion of definitive SBRT to the lung for patients with medically inoperable early stage NSCLC with tumors greater than 3 cm in diameter

Secondary Objectives

1. Distant metastases free survival (DMFS)

2. Disease Free Survival (DFS)

3. Overall survival (OS)

Study design including dose escalation / cohorts

This is an open-label, single arm feasibility study of lung SBRT followed 2 to 4 weeks after completion by the addition of pembrolizumab.

Eligible patients will have biopsy-confirmed T1b-T3N0M0 (stage IA-IIB) non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC NOS), performance status 0-2, deemed medically inoperable by a thoracic surgeon or pulmonologist, and no contraindications to pembrolizumab.

The primary endpoint for this study is safety and feasibility. For the first stage of this study, 8 patients will be enrolled. If >7 of the initial 8 patients complete the therapy without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity, an additional 7 patients will be enrolled for a total of 15 patients. If >2 of the original 8 patients (>25%) experience a Grade >3 pulmonary toxicity or any Grade >4 toxicity the trial will be closed and the study therapy will be considered too toxic. If >4 of 15 patients (>26.7%) experience a Grade >3 pulmonary toxicity or any Grade >4 toxicity, the study drug regimen will be deemed too toxic and unsafe. If >12 out of 15 patients complete the study without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity, the study drug regimen will be considered safe and feasible for further study. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

• NCT number: NCT03574220
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: February 19, 2019
• Completion date: March 21, 2020